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Title:
VAGINAL MICROBIOTA COMPOSITIONS FOR USE IN INFERTILITY
Document Type and Number:
WIPO Patent Application WO/2024/052864
Kind Code:
A1
Abstract:
The invention relates to substantially complete vaginal microbiota preparations for treating infertility and therapeutic methods to do so.

Inventors:
VAN HYLCKAMA VLIEG JOHAN E T (DK)
BOSMA ELLEKE (DK)
MORTENSEN BRYNJULF (DK)
DELONG KEVIN (DK)
ENSIGN LAURA (DK)
Application Number:
PCT/IB2023/058891
Publication Date:
March 14, 2024
Filing Date:
September 07, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
FREYA BIOSCIENCES APS (DK)
International Classes:
A61K35/747; A61K35/741; A61P15/02; A61P15/06; C12Q1/6869; G01N33/50
Domestic Patent References:
WO2016100086A12016-06-23
WO2020007780A12020-01-09
Foreign References:
US20200330529A12020-10-22
US20220184154A12022-06-16
US20220243247A12022-08-04
Other References:
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"Campisciano, et al Subclinical alteration of the cervical-vaginal microbiome in women with idiopathic infertility", J CELL PHYSIOL., vol. 232, no. 7, pages 1681 - 1688
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ANAHTAR MN, BYRNE EH, DOHERTY KE, BOWMAN BA, YAMAMOTO HS, SOUMILLON M,PADAVATTAN N, ISMAIL N, MOODLEY A, SABATINI ME, GHEBREMICHAE: "Cervicovaginal bacteria are a major modulator of host inflammatory responses in the female genital tract", IMMUNITY, vol. 42, 2015, pages 965 - 976, XP055696950, Retrieved from the Internet DOI: 10.1016/j.immuni.2015.04.019
LENNARD KDABEE SBARNABAS SLHAVYARIMANA EBLAKNEY AJAUMDALLY SZBOTHA GMKHIZE NNBEKKER L-GLEWIS DA: "2018. Microbial composition predicts genital tract inflammation and persistent bacterial vaginosis in South African adolescent females", INFECT IMMUN, vol. 86, pages e00410 - 17, Retrieved from the Internet
MASSON LMLISANA KLITTLE FWERNER LMKHIZE NNRONACHER KGAMIELDIEN HWILLIAMSON CMCKINNON LRWALZL G: "Defining genital tract cytokine signatures of sexually transmitted infections and bacterial vaginosis in women at high risk of HIV infection: a cross-sectional study", SEX, vol. 90, 2014, pages 580 - 588, Retrieved from the Internet
FICHOROVA RN, MORRISON CS, CHEN P-L, YAMAMOTO HS, GOVENDER Y, JUNAID D, RYAN S.,KWOK C, CHIPATO T, SALATA RA, DONCEL GF: "Aberrant cervical innate immunity predicts onset of dysbiosis and sexually transmitted infections in women of reproductive age", PLOS ONE, vol. 15, 2020, pages e0224359, Retrieved from the Internet
GARRETT NMTSHALI, AOSMAN, F ET AL.: "Impact of point-of-care testing and treatment of sexually transmitted infections and bacterial vaginosis on genital tract inflammatory cytokines in a cohort of young South African women", SEX TRANSM INFECT, vol. 97, no. 8, 2021, pages 555 - 565
CAMARGO CAMPOS AC, CANDIDO MURTA EF, MICHELIN MA, REIS C: "Evaluation of Cytokines in Endocervical Secretion and Vaginal pH from Women with Bacterial Vaginosis or Human Papillomavirus", OBSTETRICS AND GYNECOLOGY, vol. 2012
CHERNE MDCOLE ALNEWBERRY LSCHMIDT-OWENS MDEICHEN MCOLE AM: "Matrix Metalloproteinases Expressed in Response to Bacterial Vaginosis Disrupt the Endocervical Epithelium, Increasing Transmigration of HIV", INFECT IMMUN, vol. 88, no. 4, 23 March 2020 (2020-03-23), pages e00041 - 20
HAAHR T ET AL.: "Abnormal vaginal microbiota may be associated with poor reproductive outcomes: a prospective study in IVF patients", HUM REPROD, vol. 31, no. 4, 23 February 2016 (2016-02-23), pages 795 - 803, XP055492354, DOI: 10.1093/humrep/dew026
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MORENO I ET AL.: "Endometrial microbiota composition is associated with reproductive outcome in infertile patients", MICROBIOME, vol. 10, no. 1, January 2022 (2022-01-01), pages 1, XP021300690, DOI: 10.1186/s40168-021-01184-w
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Claims:
  CLAIMS What is claimed is: 1.  A composition for use in a method of treating an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract, said method comprising administering to the subject an effective amount of the composition to the genitourinary tract to treat infertility, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. 2. A composition for use in a method of treating inflammation in the genitourinary tract of an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract, said method comprising administering to the subject an effective amount of the composition to treat inflammation in the genitourinary tract, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. 3. A composition for use in a method of treating dysbiosis in the genitourinary tract of an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract, said method comprising administering to the subject an effective amount of the composition to treat the dysbiosis in the genitourinary tract, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising:

152  \\4163‐8733‐4730  v3      (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. 4.   A composition for use in a method of increasing the rate of pregnancy and/or live births, e.g., by promoting embryo implantation and/or embryo retention, in a population of female subjects, optionally a population of infertile female subjects, wherein each of the subjects in the population exhibits a dysbiotic microbiota in the genitourinary tract, said method comprising administering to each of the subjects an effective amount of the composition to the genitourinary tract to increase the rate of pregnancy and/or live births, wherein the composition comprises: a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; and wherein the rate of pregnancy and/or live births is increased in the population of female subjects being administered the composition relative to a control population. 5. A composition for use in a method of reducing the rate of pregnancy loss (e.g., miscarriage) in a population of female subjects, optionally a population of infertile female subjects, wherein each of the subjects in the population exhibits a dysbiotic microbiota in the genitourinary tract, said method comprising administering to each of the subjects an effective amount of the composition to the genitourinary tract to reduce the rate of pregnancy loss, wherein the composition comprises: a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus

153  \\4163‐8733‐4730  v3      gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; and wherein the rate of pregnancy loss is reduced in the population of female subjects being administered the composition relative to a control population. 6. The composition for use of any one of the preceding claims, wherein the preparation comprises one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation. 7. The composition for use of any one of the preceding claims, wherein the preparation comprises one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 90-99.9% of all detectable bacterial species of the preparation. 8. The composition for use of any one of the preceding claims, wherein at least 90% of all detectable bacterial species of the preparation are Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri. 9. The composition for use of any one of the preceding claims, wherein at least 95% of all detectable bacterial species of the preparation are Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri. 10. The composition for use of any one of the preceding claims, wherein at least 98% of all detectable bacterial species of the preparation are Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri. 11. The composition for use of any one of the preceding claims, wherein less than 90% of the detectable bacterial species in a sample of the dysbiotic microbiota obtained from the

154  \\4163‐8733‐4730  v3      genitourinary tract of the infertile female subject belong to the genus Lactobacillus selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. 12. The composition for use of any one of the preceding claims, wherein less than 85%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, or 10% of the detectable bacterial species in a sample of the dysbiotic microbiota obtained from the genitourinary tract of the infertile female subject belong belong to the genus Lactobacillus selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. 13.  The composition for use of any one of the preceding claims, wherein the infertile female subject is exhibiting one or more infertility conditions, or the population of infertile female subjects is a population of subjects exhibiting one or more conditions associated with infertility. 14.  The composition for use of claim 13, wherein the one or more conditions associated with infertility is selected from the group consisting of: pelvic inflammatory disease (PID), endometritis, tubal factor infertility, endometriosis, anovulation and polycystic ovary syndrome (PCOS). 15.  The composition for use of claim 13 or 14, wherein the one or more conditions associated with infertility is pelvic inflammatory disease (PID). 16. The composition for use of claim 13 or 14, wherein the one or more conditions associated with infertility is endometritis. 17. The composition for use of claim 13 or 14, wherein the one or more conditions associated with infertility is idiopathic infertility. 18. The composition for use of claim 13 or 14, wherein the one or more conditions associated with infertility is tubal factor infertility.

155  \\4163‐8733‐4730  v3      19. The composition for use of claim 13 or 14, wherein the one or more conditions associated with infertility is endometriosis. 20. The composition for use of claim 13 or 14, wherein the one or more conditions associated with infertility is polycystic ovary syndrome (PCOS). 21. The composition for use of any one of the preceding claims, wherein, following administration of the composition, the female subject(s) is determined to have a detectable level of beta hCG hormone (e.g., detected using a pregnancy test). 22. The composition for use of any one of the preceding claims, wherein, following administration of the composition, the female subject(s) is determined to have a clinical pregnancy. 23. The composition for use of any one of the preceding claims, wherein, following administration of the composition, the female subject(s) maintains an ongoing pregnancy (e.g., to live birth). 24. The composition for use of any one of the preceding claims, wherein, following administration of the composition, the female subject(s) does not have a pregnancy loss (e.g., miscarriage). 25.  The composition for use of any one of the preceding claims, wherein the method increases the number of females determined to have a detectable level of beta hCG hormone (e.g., detected using a pregnancy test) in a population of female subjects being administered the composition, relative to a control population. 26. The composition for use of any one of the preceding claims, wherein the method increases the rate of clinical pregnancies in a population of female subjects, relative to a control population.

156  \\4163‐8733‐4730  v3      27. The composition for use of any one of the preceding claims, wherein the method increases the rate of live births in a population of female subjects, relative to a control population. 28. The composition for use of any one of the preceding claims, wherein the method reduces the rate or occurrence of pregnancy losses in a population of female subjects, relative to a control population 29. The composition for use of any one of the preceding claims, wherein the population of female subjects comprises at least 10, at least 20 or at least 40 female subjects. 30. The composition for use of any one of claims 5-29, wherein the rate of early-term pregnancy loss is reduced in a population of female subjects, wherein an early-term pregnancy loss is a pregnancy loss that occurs 1 day, 2 days, 3 days, up to 1 week, up to 2 weeks, up to 3 weeks, up to 4 weeks, or up to 12 weeks following onset of the pregnancy. 31. The composition for use of any one of claims 5-29, wherein the rate of late-term pregnancy loss is reduced in a population of female subjects, wherein a late-term pregnancy loss is a pregnancy loss that occurs more than 12 weeks following onset of the pregnancy. 32. The composition for use of any one of the preceding claims, wherein the female subject is an asymptomatic dysbiotic female subject, or the population of female subjects is a population of asymptomatic dysbiotic female subjects. 33. The composition for use of any one of the preceding claims, wherein the female subject does not exhibit or has not been diagnosed with having bacterial vaginosis or a fungal infection (e.g., candidiasis), or the population of female subjects is a population that does not exhibit or has not been diagnosed with having bacterial vaginosis or a fungal infection (e.g., candidiasis). 34. The composition for use of any one of the preceding claims, wherein the subject(s) is/are 15-34 years of age.

157  \\4163‐8733‐4730  v3      35.  The composition for use of claim 34, wherein the subject(s) has/have been unable to conceive after 12 months of unprotected sexual intercourse with one or more men, e.g., a subject less than 35 years old. 36. The composition for use of any one of claims 1-33, wherein the subject(s) is/are 35-50 years of age. 37. The composition for use of any one of the claims 1-33, wherein the subject(s) is/are between 20 and 45 years of age or between 20 and 42 years of age. 38. The composition for use of any one of claims 36-37, wherein the subject(s) has/have been unable to conceive after 6 months of unprotected sexual intercourse with one or more men, e.g., a subject of age 35 years or older. 39. The composition for use of any one of the preceding claims, wherein the subject(s) is/are a pre-menopausal female subject. 40. The composition for use of any one of the preceding claims, wherein the subject(s) is suffering from recurrent implantation failure (RIF). 41. The composition for use of any one of the preceding claims, wherein the infertile female subject is undergoing an assisted reproductive technology procedure, or the population of infertile female subjects is a population of subjects undergoing an assisted reproductive technology procedure. 42.  The composition for use of claim 41, wherein the assisted reproductive technology procedure is in vitro fertilization or intracytoplasmic sperm injection (ICSI). 43.  The composition for use of any one of the preceding claims, wherein the female subject is undergoing intrauterine insemination or treatments to stimulate follicular development and

158  \\4163‐8733‐4730  v3      oocyte available for fertilization or the population of female subjects is a population of subjects undergoing intrauterine insemination or treatments to stimulate follicular development and oocyte available for fertilization. 44. The composition for use of any one of the preceding claims, wherein the composition is formulated into a dosage form; wherein the dosage form comprises an effective amount of the composition in one or more discrete units, wherein the effective amount is predetermined. 45. The composition for use of any one of the preceding claims, wherein the female subject is not treated with an antibiotic prior to administration of the composition. 46. The composition for use of any one of the preceding claims, wherein the composition is administered to the vaginal cavity of the subject. 47. The composition for use of any one of the preceding claims, wherein the composition is administered to the endometrium of the subject. 48. The composition for use of claim 46 or 47, wherein prior to administering the composition, a vaginal wash is performed and/or wherein the vaginal wash is subsequently rinsed with saline and/or lactic acid. 49.  The composition for use of claim 48, wherein the vaginal wash is performed with saline, lactic acid or an antiseptic agent, optionally wherein the antiseptic agent is povidone-iodine, chlorhexidine, chlorhexidine gluconate, cetrimide, or a mixture of chlorhexidine and cetrimide. 50. The composition for use of any one of claims 1-44 or 46-49, wherein (a) the subject has been diagnosed with bacterial vaginosis or a vaginal infection (e.g., bacterial or fungal infection), and wherein the female subject is pre-treated with an antibiotic and/or anti-fungal prior to administration of the composition, and optionally, wherein the composition is administered to the subject after the subject’s bacterial vaginosis or the vaginal infection is clinically resolved; or (b)

159  \\4163‐8733‐4730  v3      wherein the subject has not been diagnosed with bacterial vaginosis or a vaginal infection, wherein the female subject is not pre-treated with an antibiotic and/or antifungal prior to administration of the composition. 51. The composition for use of any one of the preceding claims, wherein the female subject exhibits endometrial and/or vaginal inflammation. 52.  The composition for use of any one of the preceding claims, wherein the subject has elevated levels of pro-inflammatory or inflammasome-associated cytokines, proteins, metabolites, receptor or signaling molecules in the vagina, endometrium, and/or in the reproductive tract, relative to a control. 53. The composition for use of any one of the preceding claims, wherein the subject has elevated systemic levels of pro-inflammatory or inflammasome-associated cytokines, proteins, metabolites, receptor or signaling molecules (e.g., as measured in blood, e.g., venous blood). 54. The composition for use of any one of the preceding claims, wherein the subject has elevated levels of pro-inflammatory or inflammasome-associated cytokines, proteins, metabolites, receptor or signaling molecules in menstrual blood (e.g., to detect local inflammation). 55. The composition for use of any one of claims 52-54, wherein the pro-inflammatory or inflammasome-associated cytokines comprise at least one of IL-1α, IL-1β, IL-2, IL-5, IL-6, IL-8, IL-12, IL-15, IL-17, IL-18, IP-10, MCP-1, TNFα, HIF-1α, COX-2 and VEGF, optionally wherein the pro-inflammatory or inflammasome-associated cytokines comprise at least one of IL-1, IL-1α, IL-1β, IL-6, or IL-18, or any combination thereof. 56. The composition for use of any one of claims 52-54, wherein the pro-inflammatory or inflammasome-associated cytokines comprise IL-1α, IL-1β, IL-2, IL-5, IL-8, IL-15, IL-17, IP- 10, COX-2, VEGF, IL-1α, IL-1β, and/or IL-18.

160  \\4163‐8733‐4730  v3      57.  The composition for use of any one of the preceding claims, wherein the subject has elevated levels of Th1 cytokines in the vagina, endometrium, and/or in the reproductive tract, relative to a control. 58. The composition for use of claim 57, wherein the Th1 cytokines comprise at least one of IFNγ, IL-12, STAMBP or TNF. 59. The composition for use of any one of the preceding claims, wherein the subject is further characterized by reduced levels of IGF-1, IL-4, IL-10, TGFβ and/or CCL5 in the vagina, endometrium, and/or in the reproductive tract, relative to a control. 60. The composition for use of any one of the preceding claims, wherein the subject is further characterized by systemically reduced levels of IGF-1, IL-4, IL-10, TGFβ and/or CCL5, relative to a control. 61. The composition for use of any one of the preceding claims, wherein after administration of the composition to the subject exhibits one or more of: (a) the elevated levels of pro-inflammatory or inflammasome-associated cytokines in the subject are reduced, optionally wherein the elevated levels of IL-2, IL-5, IL-15, IL-17, and/or IP- 10 in the subject are reduced; (b) the elevated levels of Th1 cytokines in the subject are reduced, optionally wherein the elevated levels of IFNγ in the subject are reduced; and/or (c) the reduced levels of IGF-1, IL-4, IL-10, TGFβ and/or CCL5 in the subject are increased, optionally wherein the reduced levels of TGFβ in the subject are increased. 62. The composition for use of any one of the preceding claims, wherein the substantially complete vaginal microbiota preparation further comprises vaginal transudate and/or mucus, optionally wherein the mucus is cervicovaginal mucus. 63. The composition for use of any one of the preceding claims, wherein the substantially complete vaginal microbiota preparation was obtained from a donor subject and further wherein

161  \\4163‐8733‐4730  v3      the substantially complete vaginal microbiota preparation comprises substantially all detectable bacterial, viral, fungal species, and/or metabolites, that are present in the genitourinary tract, e.g. the vagina, cervix and/or uterus, of the donor subject. 64. The composition for use of any one of the preceding claims, wherein the composition further comprises a pharmaceutically acceptable carrier or diluent, optionally wherein the diluent is saline. 65. The composition for use of any one of the preceding claims, wherein the method further comprises transferring of a human embryo to the subject. 66.  The composition for use of claim 65, wherein the human embryo has not previously been cryopreserved (e.g., the human embryo is a fresh embryo transfer). 67.  The composition for use of claim 65, wherein the human embryo has previously been cryopreserved (e.g., frozen embryo transfer (FET)). 68.  The composition for use of any one of claims 65-67, wherein the human embryo is transferred after 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 10 weeks, 12 weeks, or up to 24 weeks after administering the composition. 69.  The composition for use of any one of claims 65-67, wherein the human embryo is transferred about 6-10 weeks after administering the composition (e.g., 2 menstrual cycles). 70. The composition for use of any one of the preceding claims, wherein the method further comprises one or more of: (a) determining a partial or complete reversal of the subject´s dysbiotic vaginal microbiota after administration of the composition such that the subject’s vaginal microbiota comprises one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 90- 99.9% of all detectable bacterial species of the preparation;

162  \\4163‐8733‐4730  v3      (b) determining a reduction of pro-inflammatory or inflammasome-associated cytokines (e.g., IL-2, IL-5, IL-15, IL-17, and/or IP-10); and/or (c) determining a reduction of Th1 cytokines (e.g., IFNγ). 71. The composition for use of any one of the preceding claims, wherein a single dose or multiple doses of the composition are administered to the subject. 72.  The composition for use of claim 71, wherein multiple doses of the composition are administered to the subject over multiple days, optionally consecutive days. 73. The composition for use of claim 71 or 72, wherein three doses of the composition are administered to the subject, optionally wherein one dose is administered to the subject on each of three consecutive days. 74. The composition for use of claim 71 or 72, wherein two doses of the composition are administered to the subject, optionally wherein one dose is administered to the subject on each of two consecutive days. 75. The composition for use of any one of claims 71-74, wherein a dose of the composition is at least 1x104 colony forming units (CFUs). 76. The composition for use of any one of claims 71-74, wherein a dose of the composition is 1x103 to 1x1012 colony forming units (CFUs). 77. The composition for use of any one of the preceding claims, wherein the composition is administered repeatedly until the subject´s dysbiotic vaginal microbiota is Lactobacillus- dominant, e.g., comprises at least 60%, 70%, 80%, 90% or 95% Lactobacillus species, wherein the species are selected from Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri.

163  \\4163‐8733‐4730  v3      78. The composition for use of any one of the preceding claims, the lactobacilli comprised in the substantially complete vaginal microbiota preparation are capable of stably engrafting (e.g., colonizing) the subject´s vaginal or uterine cavity for a time period of at least 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 18 months, 24 months or longer. 79. The composition for use of any one of the preceding claims, wherein about 80-99.9% of all detectable bacterial species of the preparation consist of Lactobacillus crispatus. 80. The composition for use of any one of the preceding claims, wherein about 80-99.9% of all detectable bacterial species of the preparation consist of (f) Lactobacillus crispatus; (g) Lactobacillus crispatus and Lactobacillus jensenii; (h) Lactobacillus crispatus and Lactobacillus gasseri; (i) Lactobacillus gasseri and Lactobacillus jensenii; or (j) Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus jensenii. 81. The composition for use of claim 80, wherein for (b) to (e) Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri are present in greater relative quantity than one or more of the other vaginal lactobacilli present in the preparation. 82. The composition for use of any one of the preceding claims, wherein less than 10% of all detectable bacterial species of the dysbiotic vaginal microbiota in the genitourinary tract of the female subject belong to the genus Lactobacillus, and at least 20%, 30%, 40%, 50%, 60%, 70% or more of all detectable bacterial species of the dysbiotic vaginal microbiota are pathogens or pathobionts comprising Gardnerella spp., Atopobium spp., and/or Prevotella spp.. 83. The composition for use of any one of the preceding claims, wherein the composition is in the form of a suspension, spray, gel, cream, ointment, a lubricant, semi-solid foam, film, powder, capsule, solution for lavages or douches, ovules, a vaginal insert, tampon, tablets or a microencapsulated product.

164  \\4163‐8733‐4730  v3      84. The composition for use of any one of the preceding claims, said composition comprising at least about 104 viable bacterial cells, preferably at least about 105 viable bacterial cells. 85. The composition for use of any one of the preceding claims, said composition further comprising further lactobacilli other than Lactobacillus crispatus, Lactobacillus jensenii, or Lactobacillus gasseri, wherein the further lactobacilli are present in a concentration of about 0.01 – 1% of all detectable bacterial species of the preparation, optionally wherein the further lactobacilli are Atopobium spp., Bifidobacterium vaginale, Fannyhessea vaginae, and/or Prevotella spp. 86. The composition for use any one of the preceding claims, wherein the substantially complete vaginal microbiota preparation is obtained by a culture-independent method. 87. A method of producing a substantially complete vaginal microbiota preparation, said method comprising (a) Processing a microbiota sample from a donor female genitourinary tract, e.g. a vaginal mucosal sample or cervicovaginal secretion, comprising urogenital microbes and vaginal mucosal fluid from the vaginal cavity of a healthy donor subject in a centralized processing facility, (b) Assessing the absence of one or more pathogens, (c) Assessing viability and/or quantity of the urogenital microbes, and (d) Releasing the composition comprising the processed vaginal mucosal sample from quarantine for use in an assisted reproductive technology procedure, if a predetermined level is obtained in step (b) and (c). 88. The method of claim 87, wherein the method of obtaining the preparation further comprises one, two, three, four or all of: (e) Adding at least one pharmaceutically acceptable diluent, excipient or carrier; (f) Adjusting the pH, osmolarity and/or viscosity of the vaginal mucosal fluid; (g) Adding one or more cryoprotectants (e.g., for freezing) and/or one or more lyoprotectants (e.g., for drying);

165  \\4163‐8733‐4730  v3      (h) Formulating the processed mucosal fluid into a dosage form comprising a powder, a solid, a semi-solid, or a liquid: (i) Partitioning the vaginal mucosal fluid into discrete units, each unit comprising an effective dose of urogenital microbes, wherein the effective dose of urogenital microbes comprises at least 105 colony forming units (CFU), preferably at least 106 colony forming units (CFU), more preferably at least 107 colony forming units (CFU); (j) Storing the refrigerated, frozen or dried vaginal mucosal fluid sample or processed preparation under quarantine; (k) Holding the refrigerated, frozen or dried vaginal mucosal fluid sample or processed preparation under quarantine until any completion of any combination of (a) testing the donor to exclude the substantial presence of one or more transmissible pathogens, (b) confirming the composition and viability of the urogenital microbes comprised, or (c) further confirming the health of the donor by a plurality of post- screening tests; (l) Standardizing the cell count and/or the quantity or concentration of the urogenital microbes comprised in the preparation, optionally by adding an inert filler; and (m) Releasing the refrigerated, frozen or dried mucosal fluid sample or processed preparation from quarantine to define the substantially complete vaginal microbial preparation. 89. The method of claim 88, wherein the preparation comprises (i) one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri, which comprise 90-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. 90. A method of determining whether a subject undergoing an assisted reproductive technology procedure benefits from administration of a composition, the method comprising: (a) obtaining a sample of the microbiota of the genitourinary tract of the subject; (b) profiling the species content of the sample;

166  \\4163‐8733‐4730  v3      (c) determining the relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri within the sample, wherein the subject benefits from administration of a composition if the relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri is less than 95% or less than 90% of the total abundance of all detectable bacterial species of the sample, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. 91. The method of claim 90, wherein the subject is characterized as exhibiting a dysbiotic microbiota in the genitourinary tract if the relative abundance Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri within the sample is less than 90% of all detectable bacterial species. 92. A method of determining whether a subject undergoing an assisted reproductive technology procedure benefits from administration of a composition, the method comprising determining one, two, or three of: (a) the number of prior assisted reproductive technology (e.g., IVF) cycles attributable to the subject; (b) the age of the subject; and/or (c) the number of previous pregnancy losses suffered by the subject; wherein the subject benefits from administration of a composition if the number of prior assisted reproductive technology (e.g., IVF) cycles is two or fewer; the age of the subject is about 42 or less; and/or the number of previous pregnancy losses is two or fewer, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.

167  \\4163‐8733‐4730  v3      93. The method of claim 92, wherein the method comprises determining (a) and (b); (a) and (c); (b) and (c); or (a), (b), and (c). 94. A method comprising: (a) obtaining a sample of the microbiota of the genitourinary tract of a female subject; (b) profiling the species content of the sample; (c) determining the relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri within the sample; (d) administering a composition to the subject if the relative abundance Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri within the sample is less than 90% of all detectable bacterial species, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; and (e) subjecting the subject to an assisted reproductive technology procedure. 95. The method of any one of claims 90-94, wherein the assisted reproductive technology procedure is in vitro fertilization or intracytoplasmic sperm injection (ICSI). 96. A pharmaceutical composition comprising a substantially complete vaginal microbiota preparation, wherein the composition comprises (i) a cervico-vaginal secretion (CVS) that comprises a combined vaginal Lactobacillus, comprising one or more of: lactobacillus crispatus, lactobacillus jensenii, and lactobacillus gasseri relative abundance above 80% and combined Gardnerella, Atopobium, and Prevotella relative abundance below 5%, and (ii) normal, sterile saline, wherein the CVS and the saline form a suspension, wherein the composition has a pH 4.5 or less (e.g., between about pH 3.0 to 4.5), and comprises at least 1x105 colony forming units (CFU).

168  \\4163‐8733‐4730  v3      97. The pharmaceutical composition of claim 96, wherein the composition does not comprise detectable levels of sperm cells. 98. The pharmaceutical composition of claim 96 or 97, comprises about 0.1-0.3 ml CVS and about 1.0 ml of saline. 99. The pharmaceutical composition of any one of claims 96-98, wherein the composition comprises a dosage form comprising a sterile cryovial comprising between about 1.1-1.5 ml of the composition, and optionally stored frozen. 100. The pharmaceutical composition of any one of claims 96-99, wherein the cervicovaginal secretion (CVS) comprises a combined vaginal Lactobacillus relative abundance above 90% or above 95%, optionally up to 99.9%. 101. The pharmaceutical composition of any one of claims 96-100 for use in any one of claims 1-86. 102. The pharmaceutical composition of any one of claims 96-100 obtainable by any method of claims 87-89.

169  \\4163‐8733‐4730  v3   

Description:
            VAGINAL MICROBIOTA COMPOSITIONS FOR USE IN INFERTILITY RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application number 63/404,867, filed September 8, 2022, the content of which is incorporated by reference herein in its entirety. BACKGROUND OF THE INVENTION Infertility affects at least 11% of women globally. Many couples turn to in vitro fertilization (IVF) to overcome their infertility problems. During IVF, ovulation is induced, mature eggs are retrieved from the ovaries, and subsequently in vitro fertilized with sperm. The embryo is transferred to the uterus, where it will implant in the uterine lining and continue to develop. In Europe, on average about a third of IVF embryo transfers result in clinical pregnancy. The successful implantation is a highly organized process, wherein the embryo attaches to the endometrial surface of a receptive uterus and invades the epithelium and then the maternal circulation to form the placenta. It requires a dynamic cascade of gene activation and repression in the uterus, and a highly synchronized cross-talk between the embryo and the uterus. Embryo implantation or the failure thereof represents a substantial problem for infertility patients particularly patients with recurrent implantation failure (RIF), defined as multiple failed transfers of high-quality embryos. While IVF is the most effective form to overcome infertility, many women undergoing IVF will not become pregnant, inter alia due to failed embryo implantation, which is one of the most rate-limiting steps of IVF procedures. This poses a challenge to fertility specialists and puts the women and couples under emotional and financial strain. Additionally, endometriosis, a chronic inflammatory disease, can cause tissue similar to the lining of the uterus to grow outside of the uterus, which leads to severe, life-impacting pain and/or infertility. Thus, there remains a need to improve treatment of infertility in women. SUMMARY OF THE INVENTION The present invention addresses this unmet need by providing therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions 1  \\4163‐8733‐4730  v3                comprising the same for use in conditions and procedures associated with human infertility, specifically female infertility. In one example, a substantially complete vaginal microbiota preparation as described herein can be used to treat infertility in women with dysbiotic vaginal microbiota who are undergoing Assisted Reproductive Technology (ART). A dysbiotic vaginal microbiota is defined, in some embodiments, as a vaginal microbiome having less than 90% relative abundance of three selected Lactobacillus species – Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii). In one example, the therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions comprising the same can be used to treat infertility in women who undergo or planning to undergo an assisted reproductive procedure of fertility regimen. In some embodiments, the assisted reproductive procedure is in vitro fertilization (IVF). In another example, the therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions comprising the same can be used to treat infertility in women exhibiting endometriosis which may increase pregnancy outcomes prior to an IVF procedure. In another example, the therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions comprising the same can be used to treat infertility in women exhibiting endometriosis undergoing an IVF procedure. In another example, the therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions comprising the same can be used to treat infertility in women who does exhibit one or more of endometriosis or another condition associated with reduced fertility, such as, e.g., polycystic ovary syndrome (PCOS), tubal factor infertility, pelvic inflammatory disease (PID), and/or ovulatory disorder. In some embodiments, the reduced fertility is associated with PCOS. In some embodiments, the reduced fertility is associated with tubal factor infertility. In some embodiments, the reduced fertility is associated with PID. In some embodiments, the reduced fertility is associated with ovulatory disorder. In another example, the therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions comprising the same can be used to treat infertility in women who does not exhibit endometriosis, or another condition associated with reduced 2  \\4163‐8733‐4730  v3                fertility, such as, e.g., polycystic ovary syndrome (PCOS), tubal factor infertility, pelvic inflammatory disease (PID), and/or ovulatory disorder undergoing an IVF procedure. In some embodiments, the reduced fertility is idiopathic. In some embodiments, the therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions comprising the same can be used to treat microbial dysbiosis in the reproductive (e.g., uterine and vaginal) tract of an infertile woman. It is thought that the uterine and/or vaginal microbiome may be associated with poor reproductive outcomes, e.g., in IVF patients (Haahr T et al., Vaginal Microbiota and In vitro Fertilization Outcomes: Development of a Simple Diagnostic Tool to Predict Patients at Risk of a Poor Reproductive Outcome. J Infect Dis.2019 May 5;219(11):1809-1817). The microbial composition has been suggested to be predictive of reproductive outcome (Moreno I et al., Endometrial microbiota composition is associated with reproductive outcome in infertile patients. Microbiome.2022 Jan 4;10(1):1). In some embodiments, dysbiosis is associated with a pro-inflammatory tone of the reproductive (e.g., uterine and vaginal) tract, e.g., with the presence of (local) inflammation in the reproductive tract, e.g., as can be measured by one or more pro- inflammatory biomarkers. The pro-inflammatory (local) environment (e.g., the vaginal and/or endometrial epithelium) is thought to disrupt the highly organized process of embryo implantation and may render the endometrial surface less receptive. Thus, the vaginal and endometrial microbiome might impact the environment for embryo implantation and may contribute to implantation success (e.g., healthy microbiome) or failure (dysbiotic microbiome, e.g., promoting inflammation). In some embodiments, the therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions comprising the same can be used to treat infertility, e.g., by promoting embryo implantation in a female subject exhibiting a dysbiosis in the reproductive tract, e.g., a female subject harboring a dysbiotic microbiome that is, e.g., associated with -or causative of- a pro-inflammatory female host response in the reproductive tract. In some embodiments, the female subject undergoes (or is planning to undergo) in vitro fertilization (IVF). In some embodiments, the compositions and substantially complete vaginal microbiota preparations are effective in modulating the receptivity of the uterus, thereby increasing pregnancy success. In some embodiments, the success rate of IVF is 3  \\4163‐8733‐4730  v3                increased, e.g., a lower number of IVF cycles are required to produce a successful pregnancy, thereby reducing the cost of infertility related services and the emotional toll of repeated IVF cycles (e.g., a first IVF cycle and subsequent IVF cycles). In some embodiments, the number of embryo transfers (e.g., during one IVF cycle) required to achieve embryo implantation and successful pregnancy (e.g., as assessed by fetal heartbeat) is reduced when compared to a control group not receiving the compositions and substantially complete vaginal microbiota preparations. This can be assessed over a population of subjects, e.g., a plurality of IVF cycles. A reduction in the number of required embryo transfers significantly affects health care costs. In some embodiments, the therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions comprising the same can be used to decreases the likelihood of an undesirable reproductive outcome, including implantation failure of the zygote or embryo which is often perturbed in infertile women. It is thought that healthy vaginal microbiota balance pro-inflammatory processes that are triggered by the fetus’ implantation, and anti-inflammatory, tolerogenic processes that cause the embryo to implant into the uterine wall and allow pregnancy to proceed. A pro-inflammatory immune tone (e.g., caused by dysbiotic microbiota) in the vaginal niche decreases embryo receptivity. In some embodiments, the therapeutic methods using substantially complete vaginal microbiota preparations or pharmaceutical compositions comprising the same can be used to reverse the dysbiosis and provide a receptive environment, e.g., a receptive uterus, for the embryo. Some aspects of the present invention disclose a composition for use in a method of treating an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract. In some embodiments, a method of treating an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract comprises administering to the subject an effective amount of the composition to the genitourinary tract to treat infertility, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80- 99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. Some aspects of the present invention disclose a composition for use in a method of treating inflammation in the genitourinary tract of an infertile female subject exhibiting a 4  \\4163‐8733‐4730  v3                dysbiotic microbiota in the genitourinary tract. In some embodiments, a method of treating inflammation in the genitourinary tract of an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract comprises administering to the subject an effective amount of the composition to treat inflammation in the genitourinary tract, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80- 99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. Some aspects of the present invention disclose a composition for use in a method of treating dysbiosis in the genitourinary tract of an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract. In some embodiments, a method of treating dysbiosis in the genitourinary tract of an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract comprises administering to the subject an effective amount of the composition to treat the dysbiosis in the genitourinary tract, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80- 99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. Some aspects of the present invention disclose a composition for use in a method of increasing the rate of pregnancy and/or live births, e.g., by promoting embryo implantation and/or embryo retention, in a population of female subjects, optionally a population of infertile female subjects, wherein each of the subjects in the population exhibits a dysbiotic microbiota in the genitourinary tract. In some embodiments, a method of increasing the rate of pregnancy and/or live births, e.g., by promoting embryo implantation and/or embryo retention, in a population of female subjects comprises administering to each of the subjects an effective amount of the composition to the genitourinary tract to increase the rate of pregnancy and/or live births, wherein the composition comprises: a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus 5  \\4163‐8733‐4730  v3                gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; and wherein the rate of pregnancy and/or live births is increased in the population of female subjects being administered the composition relative to a control population. Some aspects of the present invention disclose a composition for use in a method of reducing the rate of pregnancy loss (e.g., miscarriage) in a population of female subjects, optionally a population of infertile female subjects, wherein each of the subjects in the population exhibits a dysbiotic microbiota in the genitourinary tract. In some embodiments, a method of reducing the rate of pregnancy loss (e.g., miscarriage) in a population of female subjects comprises administering to each of the subjects an effective amount of the composition to the genitourinary tract to reduce the rate of pregnancy loss, wherein the composition comprises: a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; and wherein the rate of pregnancy loss is reduced in the population of female subjects being administered the composition relative to a control population. In some embodiments, the preparation comprises one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 90-99.9% of all detectable bacterial species of the preparation. In some embodiments, at least 90% of all detectable bacterial species of the preparation are Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri. In some embodiments, at least 95% of all detectable bacterial species of the preparation are Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri. In some embodiments, at least 98% of all detectable bacterial species of the preparation are Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri. 6  \\4163‐8733‐4730  v3                In some embodiments, the preparation has one, two, three, four or more, or all of the following characteristics: (i) processed from a donor CVS sample that comprises a combined vaginal Lactobacillus (comprising one or more of: lactobacillus crispatus, lactobacillus jensenii, and lactobacillus gasseri) relative abundance above 80% and combined Gardnerella, Atopobium, and Prevotella relative abundance below 5% (e.g., determined by metagenomic sequencing); (ii) comprises a pH < 4.5 (iii) comprises about 0.1-0.3 ml CVS sample and approximately 1.0 ml of normal, sterile saline (iv) comprises ≥ 1x105 colony forming units (CFU) (v) does not comprise any detectable sperm cells, e.g., determined by microscopy and/or laboratory analysis (e.g., acid phosphatase test) In some embodiments, the preparation comprises a dosage form comprising a sterile cryovial (e.g., 1.5 ml cryovial) comprising between about 1.1-1.5 ml of the composition, and optionally stored frozen, e.g., at -80ºC. In some embodiments, provided herein is a pharmaceutical composition comprising a substantially complete vaginal microbiota preparation, wherein the composition comprises (i) a cervico-vaginal secretion (CVS) that comprises a combined vaginal Lactobacillus, comprising one or more of: lactobacillus crispatus, lactobacillus jensenii, and lactobacillus gasseri relative abundance above 80% and combined Gardnerella, Atopobium, and Prevotella relative abundance below 5%, and (ii) normal, sterile saline, wherein the CVS and the saline form a suspension, wherein the composition has a pH 4.5 or less, and comprises at least 1x10 5 colony forming units (CFU). In some embodiments, the composition does not comprise detectable levels of sperm cells. In some embodiments, the composition comprises about 0.1-0.3 ml CVS and about 1.0 ml of saline. In some embodiments, the pharmaceutical composition comprises a dosage form comprising a sterile cryovial comprising between about 1.1-1.5 ml of the composition, and optionally stored frozen. In some embodiments, the cervicovaginal secretion (CVS) comprises a combined vaginal Lactobacillus relative abundance above 90% or above 95%, optionally up to 99.9%. In some embodiments, the compositions described herein are used 7  \\4163‐8733‐4730  v3                in the treatment methods described herein. In some embodiments, the compositions described herein are obtainable by the processing and manufacturing methods described herein. In some embodiments, less than 90% of the detectable bacterial species in a sample of the dysbiotic microbiota obtained from the genitourinary tract of the infertile female subject belong to the genus Lactobacillus selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, less than 85%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, or 10% of the detectable bacterial species in a sample of the dysbiotic microbiota obtained from the genitourinary tract of the infertile female subject belong to the genus Lactobacillus selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, the infertile female subject is exhibiting one or more infertility conditions, or the population of infertile female subjects is a population of subjects exhibiting one or more conditions associated with infertility. In some embodiments, the one or more conditions associated with infertility is selected from the group consisting of: pelvic inflammatory disease (PID), endometritis, tubal factor infertility, endometriosis, anovulation and polycystic ovary syndrome (PCOS). In some embodiments, the one or more conditions associated with infertility is pelvic inflammatory disease (PID). In some embodiments, the one or more conditions associated with infertility is endometritis. In some embodiments, the one or more conditions associated with infertility is idiopathic infertility. In some embodiments, the one or more conditions associated with infertility is tubal factor infertility. In some embodiments, the one or more conditions associated with infertility is endometriosis. In some embodiments, the one or more conditions associated with infertility is polycystic ovary syndrome (PCOS). In some embodiments, wherein, following administration of the composition, the female subject(s) is determined to have a detectable level of beta hCG hormone (e.g., detected using a pregnancy test). In some embodiments, wherein, following administration of the composition, the female subject(s) is determined to have a clinical pregnancy. In some embodiments, wherein, following administration of the composition, the female subject(s) maintains an ongoing pregnancy (e.g., to live birth). In some embodiments, wherein, following administration of the composition, the female subject(s) does not have a pregnancy loss (e.g., miscarriage). In some embodiments, wherein the method increases the number of females determined to have a detectable level of beta hCG hormone (e.g., detected using a pregnancy test) in a population of female subjects being administered the composition, relative to a control 8  \\4163‐8733‐4730  v3                population. In some embodiments, wherein the method increases the rate of clinical pregnancies in a population of female subjects, relative to a control population. In some embodiments, wherein the method increases the rate of live births in a population of female subjects, relative to a control population. In some embodiments, wherein the method reduces the rate or occurrence of pregnancy losses in a population of female subjects, relative to a control population. In some embodiments, the population of female subjects comprises at least 10, at least 20 or at least 40 female subjects. In some embodiments, the rate of early-term pregnancy loss is reduced in a population of female subjects, wherein an early-term pregnancy loss is a pregnancy loss that occurs 1 day, 2 days, 3 days, up to 1 week, up to 2 weeks, up to 3 weeks, up to 4 weeks, or up to 12 weeks following onset of the pregnancy. In some embodiments, the rate of late-term pregnancy loss is reduced in a population of female subjects, wherein a late-term pregnancy loss is a pregnancy loss that occurs more than 12 weeks following onset of the pregnancy. In some embodiments, the female subject is an asymptomatic dysbiotic female subject, or the population of female subjects is a population of asymptomatic dysbiotic female subjects. In some embodiments, the female subject does not exhibit or has not been diagnosed with having bacterial vaginosis or a fungal infection (e.g., candidiasis), or the population of female subjects is a population that does not exhibit or has not been diagnosed with having bacterial vaginosis or a fungal infection (e.g., candidiasis). In some embodiments, the subject(s) is/are 15-34 years of age. In some embodiments, the subject(s) has/have been unable to conceive after 12 months of unprotected sexual intercourse with one or more men, e.g., a subject less than 35 years old. In some embodiments, the subject(s) is/are 35-50 years of age. In some embodiments, the subject(s) is/are between 20 and 42 years of age. In some embodiments, the subject(s) has/have been unable to conceive after 6 months of unprotected sexual intercourse with one or more men, e.g., a subject of age 35 years or older. In some embodiments, the subject(s) is/are a pre- menopausal female subject. In some embodiments, the subject(s) is suffering from recurrent implantation failure (RIF). In some embodiments, the infertile female subject is undergoing an assisted reproductive technology procedure, or the population of infertile female subjects is a population of subjects 9  \\4163‐8733‐4730  v3                undergoing an assisted reproductive technology procedure. In some embodiments, the assisted reproductive technology procedure is in vitro fertilization or intracytoplasmic sperm injection (ICSI). In some embodiments, the female subject is undergoing intrauterine insemination or treatments to stimulate follicular development and oocyte available for fertilization or the population of female subjects is a population of subjects undergoing intrauterine insemination or treatments to stimulate follicular development and oocyte available for fertilization. In some embodiments, the composition is formulated into a dosage form; wherein the dosage form comprises an effective amount of the composition in one or more discrete units, wherein the effective amount is predetermined. In some embodiments, the female subject is not treated with an antibiotic prior to administration of the composition. In some embodiments, the composition is administered to the vaginal cavity of the subject. In some embodiments, the composition is administered to the endometrium of the subject. In some embodiments, prior to administering the composition, a vaginal wash is performed and/or wherein the vaginal wash is subsequently rinsed with saline and/or lactic acid. In some embodiments, the vaginal wash is performed with saline, lactic acid or an antiseptic agent, optionally wherein the antiseptic agent is povidone-iodine, chlorhexidine, chlorhexidine gluconate, cetrimide, or a mixture of chlorhexidine and cetrimide. In some embodiments, (a) the subject has been diagnosed with bacterial vaginosis or a vaginal infection (e.g., bacterial or fungal infection), and wherein the female subject is pre- treated with an antibiotic and/or anti-fungal prior to administration of the composition, and optionally, wherein the composition is administered to the subject after the subject’s bacterial vaginosis or the vaginal infection is clinically resolved; or (b) wherein the subject has not been diagnosed with bacterial vaginosis or a vaginal infection, wherein the female subject is not pre- treated with an antibiotic and/or antifungal prior to administration of the composition. In some embodiments, the female subject exhibits endometrial and/or vaginal inflammation. In some embodiments, the subject has elevated levels of pro-inflammatory or inflammasome-associated cytokines, proteins, metabolites, receptor or signaling molecules in the vagina, endometrium, and/or in the reproductive tract, relative to a control. In some 10  \\4163‐8733‐4730  v3                embodiments, the subject has elevated systemic levels of pro-inflammatory or inflammasome- associated cytokines, proteins, metabolites, receptor or signaling molecules (e.g., as measured in blood, e.g., venous blood). In some embodiments, the subject has elevated levels of pro- inflammatory or inflammasome-associated cytokines, proteins, metabolites, receptor or signaling molecules in menstrual blood (e.g., to detect local inflammation). In some embodiments, the pro- inflammatory or inflammasome-associated cytokines comprise at least one of IL-1α, IL-1β, IL-2, IL-5, IL-6, IL-8, IL-12, IL-15, IL-17, IL-18, IP-10, MCP-1, TNFα, HIF-1α, COX-2 and VEGF, optionally wherein the pro-inflammatory or inflammasome-associated cytokines comprise at least one of IL-1, IL-1α, IL-1β, IL-6, or IL-18, or any combination thereof. In some embodiments, the pro-inflammatory or inflammasome-associated cytokines comprise IL-1α, IL- 1β, IL-2, IL-5, IL-8, IL-15, IL-17, IP-10, COX-2, VEGF, IL-1α, IL-1β, and/or IL-18. In some embodiments, the subject has elevated levels of Th1 cytokines in the vagina, endometrium, and/or in the reproductive tract, relative to a control. In some embodiments, the Th1 cytokines comprise at least one of IFNγ, IL-12, STAMBP or TNF. In some embodiments, the subject is further characterized by reduced levels of IGF-1, IL- 4, IL-10, TGFβ and/or CCL5 in the vagina, endometrium, and/or in the reproductive tract, relative to a control. In some embodiments, the subject is further characterized by systemically reduced levels of IGF-1, IL-4, IL-10, TGFβ and/or CCL5, relative to a control. In some embodiments, after administration of the composition to the subject one or more of: - the elevated levels of pro-inflammatory or inflammasome-associated cytokines in the subject are reduced, optionally wherein the elevated levels of IL-2, IL-5, IL-15, IL-17, and/or IP-10 in the subject are reduced; - the elevated levels of Th1 cytokines in the subject are reduced, optionally wherein the elevated levels of IFNγ in the subject are reduced; and/or - the reduced levels of IGF-1, IL-4, IL-10, TGFβ and/or CCL5 in the subject are increased, optionally wherein the reduced levels of TGFβ in the subject are increased. In some embodiments, the substantially complete vaginal microbiota preparation further comprises vaginal transudate and/or mucus, optionally wherein the mucus is cervicovaginal mucus. In some embodiments, the substantially complete vaginal microbiota preparation was 11  \\4163‐8733‐4730  v3                obtained from a donor subject and further wherein the substantially complete vaginal microbiota preparation comprises substantially all detectable bacterial, viral, fungal species, and/or metabolites, that are present in the genitourinary tract, e.g., the vagina, cervix and/or uterus, of the donor subject. In some embodiments, the composition further comprises a pharmaceutically acceptable carrier or diluent, optionally wherein the diluent is saline. In some embodiments, the method further comprises transferring of a human embryo to the subject. In some embodiments, the human embryo has not previously been cryopreserved (e.g., the human embryo is a fresh embryo transfer). In some embodiments, the human embryo has previously been cryopreserved (e.g., frozen embryo transfer (FET)). In some embodiments, the human embryo is transferred after 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 10 weeks, 12 weeks, or up to 24 weeks after administering the composition. In some embodiments, the human embryo is transferred about 6-10 weeks after administering the composition (e.g., 2 menstrual cycles). In some embodiments, the method further comprises one or more of Determining a partial or complete reversal of the subject´s dysbiotic vaginal microbiota after administration of the composition such that the subject’s vaginal microbiota comprises one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 90-99.9% of all detectable bacterial species of the preparation; determining a reduction of pro-inflammatory or inflammasome- associated cytokines (e.g., IL-2, IL-5, IL-15, IL-17, and/or IP-10); and/or determining a reduction of Th1 cytokines (e.g., IFNγ). In some embodiments, a single dose or multiple doses of the composition are administered to the subject. In some embodiments, multiple doses of the composition are administered to the subject over multiple days, optionally consecutive days. In some embodiments, three doses of the composition are administered to the subject, optionally wherein one dose is administered to the subject on each of three consecutive days. In some embodiments, two doses of the composition are administered to the subject, optionally wherein one dose is administered to the subject on each of two consecutive days. 12  \\4163‐8733‐4730  v3                In some embodiments, a dose of the composition is at least 1x10 4 colony forming units (CFUs). In some embodiments, a dose of the composition is 1x10 3 to 1x10 12 colony forming units (CFUs). In some embodiments, the composition is administered repeatedly until the subject´s dysbiotic vaginal microbiota is Lactobacillus-dominant, e.g., comprises at least 60%, 70%, 80%, 90% or 95% Lactobacillus species, wherein the species are selected from Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri. In some embodiments, the lactobacilli comprised in the substantially complete vaginal microbiota preparation are capable of stably engrafting (e.g., colonizing) the subject´s vaginal or uterine cavity for a time period of at least 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 18 months, 24 months or longer. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation consist of Lactobacillus crispatus. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation consist of (a) Lactobacillus crispatus; (b) Lactobacillus crispatus and Lactobacillus jensenii; (c) Lactobacillus crispatus and Lactobacillus gasseri; (d) Lactobacillus gasseri and Lactobacillus jensenii; or (e) Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus jensenii; In some embodiments, for (b) to (e) Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri are present in greater relative quantity than one or more of the other vaginal lactobacilli present in the preparation. In some embodiments, less than 10% of all detectable bacterial species of the dysbiotic vaginal microbiota in the genitourinary tract of the female subject belong to the genus Lactobacillus, and at least 20%, 30%, 40%, 50%, 60%, 70% or more of all detectable bacterial species of the dysbiotic vaginal microbiota are pathogens or pathobionts comprising Gardnerella spp., Atopobium spp., and/or Prevotella spp.. In some embodiments, the composition is in the form of a suspension, spray, gel, cream, ointment, a lubricant, semi-solid foam, film, powder, capsule, solution for lavages or douches, ovules, a vaginal insert, tampon, tablets or a microencapsulated product. 13  \\4163‐8733‐4730  v3                In some embodiments, said composition comprising at least about 10 4 viable bacterial cells, preferably at least about 10 5 viable bacterial cells. In some embodiments, said composition further comprising further lactobacilli other than Lactobacillus crispatus, Lactobacillus jensenii, or Lactobacillus gasseri, wherein the further lactobacilli are present in a concentration of about 0.01 – 1% of all detectable bacterial species of the preparation, optionally wherein the further lactobacilli are Atopobium spp., Bifidobacterium vaginale, Fannyhessea vaginae, and/or Prevotella spp. In some embodiments, the substantially complete vaginal microbiota preparation is obtained by a culture-independent method. Some aspects of the present invention disclose a method of producing a substantially complete vaginal microbiota preparation, said method comprising: a. Processing a microbiota sample from a donor female genitourinary tract, e.g., a vaginal mucosal sample or cervicovaginal secretion, comprising urogenital microbes and vaginal mucosal fluid from the vaginal cavity of a healthy donor subject in a centralized processing facility, b. Assessing the absence of one or more pathogens, c. Assessing viability and/or quantity of the urogenital microbes, and d. Releasing the composition comprising the processed vaginal mucosal sample from quarantine for use in an assisted reproductive technology procedure, if a predetermined level is obtained in step (b) and (c). In some embodiments, the method of obtaining the preparation further comprises one, two, three, four or all of e. Adding at least one pharmaceutically acceptable diluent, excipient or carrier; f. Adjusting the pH, osmolarity and/or viscosity of the vaginal mucosal fluid; g. Adding one or more cryoprotectants (e.g., for freezing) and/or one or more lyoprotectants (e.g., for drying); h. Formulating the processed mucosal fluid into a dosage form comprising a powder, a solid, a semi-solid, or a liquid: i. Partitioning the vaginal mucosal fluid into discrete units, each unit comprising an effective dose of urogenital microbes, wherein the effective dose of urogenital microbes comprises at least 10 5 colony forming units (CFU), preferably at least 14  \\4163‐8733‐4730  v3                10 6 colony forming units (CFU), more preferably at least 10 7 colony forming units (CFU); j. Storing the refrigerated, frozen or dried vaginal mucosal fluid sample or processed preparation under quarantine; k. Holding the refrigerated, frozen or dried vaginal mucosal fluid sample or processed preparation under quarantine until any completion of any combination of (a) testing the donor to exclude the substantial presence of one or more transmissible pathogens, (b) confirming the composition and viability of the urogenital microbes comprised, or (c) further confirming the health of the donor by a plurality of post-screening tests; l. Standardizing the cell count and/or the quantity or concentration of the urogenital microbes comprised in the preparation, optionally by adding an inert filler; and m. Releasing the refrigerated, frozen or dried mucosal fluid sample or processed preparation from quarantine to define the substantially complete vaginal microbial preparation. In some embodiments, the preparation comprises (i) One, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri, which comprise 90-99.9% of all detectable bacterial species of the preparation; and (ii) Less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. Further aspects of the present invention disclose a method of determining whether a subject undergoing an assisted reproductive technology procedure benefits from administration of a composition, the method comprising: (a) obtaining a sample of the microbiota of the genitourinary tract of the subject; (b) profiling the species content of the sample; (c) determining the relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri within the sample, wherein the subject benefits from administration of a composition if the relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri is less than 95% or less than 90% of the total abundance of all detectable bacterial species of the sample, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: 15  \\4163‐8733‐4730  v3                (i) one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. In some embodiments, the subject is characterized as exhibiting a dysbiotic microbiota in the genitourinary tract if the relative abundance Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri within the sample is less than 90% of all detectable bacterial species. Further aspects of the present invention disclose a method of determining whether a subject undergoing an assisted reproductive technology procedure benefits from administration of a composition, the method comprising determining one, two, or three of: (a) the number of prior assisted reproductive technology (e.g., IVF) cycles attributable to the subject; (b) the age of the subject; and/or (c) the number of previous pregnancy losses suffered by the subject; wherein the subject benefits from administration of a composition if the number of prior assisted reproductive technology (e.g., IVF) cycles is two or fewer; the age of the subject is about 42 or less; and/or the number of previous pregnancy losses is two or fewer, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. In some embodiments, the method comprises determining (a) and (b); (a) and (c); (b) and (c); or (a), (b), and (c). Still further aspects of the present invention disclose a method comprising: (a) obtaining a sample of the microbiota of the genitourinary tract of a female subject; (b) profiling the species content of the sample; (c) determining the relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri within the sample; 16  \\4163‐8733‐4730  v3                (d) administering a composition to the subject if the relative abundance Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri within the sample is less than 90% of all detectable bacterial species, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; and (e) subjecting the subject to an assisted reproductive technology procedure. In some embodiments, the assisted reproductive technology procedure is in vitro fertilization or intracytoplasmic sperm injection (ICSI). BRIEF DESCRIPTION OF THE FIGURES Figure 1 is a schematic representation of the donor program to produce substantially complete vaginal microbiota preparations (SCVMPs). Donors were selected based on microbiome sequencing, a medical examination, and the absence of certain diseases. Testing was performed both before and after the donation visits. All samples provided by the donor were subjected to quality control (see, e.g., Figure 5). Samples were released only when donor and samples passed all requirements. Figure 2 shows the distribution of vaginal microbiomes from a cohort of 96 female subjects that were assessed by shotgun DNA sequencing to identify suitable donors from which to obtain cervicovaginal secretions. Relative abundance of bacteria was measured, and subjects were classified as "healthy", "dysbiotic" and "undefined" using the classification parameters indicated. Figure 3 shows stacked bar graphs of relative bacterial abundance in the donors from the cohort of 96 female subjects (see, Figure 2) with a healthy vaginal microbiome (n=61), as assessed by shotgun sequencing. All donor microbiomes in this graph contain at least 80% of vaginal Lactobacillus species (Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus jensenii, and Lactobacillus iners) or mixtures thereof, and less than 5% selected pathogens (Atopobium spp., Prevotella spp., B. vaginale, and F. vaginae) or mixtures thereof. 17  \\4163‐8733‐4730  v3                Figure 4 shows stacked bar graphs of relative bacterial abundance in the donors from the cohort of 96 female subjects (see, Figure 2) with a dysbiotic vaginal microbiome (left, n=27) or undefined microbiome (right, n=8) as assessed by shotgun sequencing. Dysbiotic microbiomes contain at least 20% species from selected vaginal pathogens (Atopobium spp., Prevotella spp., B. vaginale, and F. vaginae) or mixtures thereof, and less than 10% of vaginal Lactobacillus species (Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus jensenii, and Lactobacillus iners) or mixtures thereof. Figure 5 shows a flowchart depicting an exemplary procedure to obtain cervicovaginal secretions (CVS) and processing thereof for preparing the SCVMP. The secretions were split into samples for characterization and quality control (including, e.g., viability count, DNA sequencing and pathogen screening) and processing into a SCVMP. Figures 6A-6I show stacked bar graphs of four main Lactobacillus species present in the SCVMPs from 9 donors (6 A – 6 I) as assessed by shotgun sequencing. The results from eight representative donation visits are shown for each donor. Where present, the vertical line indicates a new round of visits as recurring donor. Figures 7A-7B show stacked bar graphs of relative bacterial abundance in two exemplary recipients (7A-7B) of a SCVMP and their respective donors, as measured by shotgun sequencing. All recipients were enrolled based on their microbiome at screening; a baseline microbiome sample was taken just prior to administration of the SCVMPs. The reversal or dissolution of the dysbiotic vaginal microbiome was stable for at least 6 months (final data for recipient 1, Fig 7A) and at least 3 months (interim data for recipient 2, Fig 7B). Figure 8 shows three different PCA plots for inflammatory markers comparing women with a dysbiotic and healthy microbiome by proteomics (Figure 8 A), transcriptomics (Figure 8 B) and metabolomics (Figure 8 C). A. PCA plot for inflammatory proteins (healthy: n=41, dysbiotic: n=19), where each dot corresponds to one woman; 92 inflammation panel markers were used as variables. The asterisk (*) indicates a woman with a healthy microbiome who might have an unrecognized infection such as, e.g., Candida. B. PCA plot for inflammatory mRNA molecules in dysbiotic and healthy subjects (healthy: n=4, dysbiotic: n=6) using Nanostring analysis.579 inflammatory markers were used as variables. C. PCA plot for small molecules associated with inflammation in dysbiotic and healthy subjects (healthy: n=5, dysbiotic: n=7) 18  \\4163‐8733‐4730  v3                using MS-omics.879 inflammatory markers were used as variables. D. Box and whisker plot of selected inflammatory markers, which are associated with bacterial vaginosis. Figures 9A-9D show plots of inflammatory markers from the inflammation panel described in Figure 8A in dysbiotic recipient pre- and post-administration with a SCVMP. PCA plot shows the shift in inflammation state in the recipient pre- and post-treatment with the SCVMP, relative to the healthy donor samples and with a subset of the screening cohort for comparison. The 92 inflammation panel markers were used as variables. Figure 10 shows a principal component analysis (PCA) plot for two recipients of a substantially complete vaginal microbiota preparation, pre- and post-dosing, and their respective donors. The variables used as input are the relative abundances of bacterial species as measured by shotgun sequencing. The same input was used as for the graphs in Figure 9. Figure 11 shows schematic outlining an exemplary design of a clinical study that administers an antibiotic with the SCVMP in subjects having vaginal dysbiosis and undergoing IVF. Figures 12A-12C show the predictive value of features of women undergoing a frozen embryo transfer (FET) for their contribution to the prediction of pregnancy after FET (SHAP value). The plotted features are prior IVF cycles (Figure 12A), total number of pregnancy losses (Figure 12B), and age (Figure 12C). Solid vertical lines indicate exclusion points. Figure 13 show the predictive value of the relative abundance of selected Lactobacillus species (L. crispatus, L. gasseri, and L. jensenii) in the vaginal microbiota of women undergoing a frozen embryo transfer (FET) for its contribution to the prediction of pregnancy after FET (SHAP value). This analysis is performed on women with two of fewer prior IVF cycles, two or fewer pregnancy losses, and age of 42 or less. Positive SHAP value provides an indicator that the relative abundance of the selected Lactobacillus species is predictive of IVF success (e.g., clinical pregnancy, live birth, etc.). The dotted vertical line demonstrates that a vaginal microbiome containing 90% or greater abundance of selected Lactobacillus species (L. crispatus, L. gasseri, and L. jensenii) is a positive predictor for IVF success in this cohort of women. Figure 14 provides results of a double-blind controlled clinical trial. It was found that the vaginal microbiome of women treated with a SCVMP (“active”) as described herein contained a statistically significant increase in the combined relative abundance of L. crispatus, L. gasseri, and L. jensenii relative to women treated with a placebo. 19  \\4163‐8733‐4730  v3                Figure 15 demonstrates that the L. crispatus single nucleotide variant (SNV) profiles of the vaginal microbiota of recipients of a SCVMP as described herein were most similar to the profile of their SCVMP donor sample (as compared to any other SCVMP donor) after administration of the donor SCVMP. (N=18) Figure 16A provides a plot of the first and second principal component analysis (PCA) of 634 biomarkers measured in CVS collected from 260 individuals. Individuals were grouped according to whether or not the combined relative abundance of L. crispatus, L. gasseri, and L. jensenii in their vaginal microbiome was greater than 95%. Ellipses are drawn one standard- deviation around the mean of the group. Figure 16B provides a correlation of the log2 of the fold-change of 634 immunological biomarkers in the vaginal microbiomes of subjects treated with SCVMP (and having a vaginal microbiome having a relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri that was 90% or greater following treatment) with the log2 of the fold- change of those biomarkers in subjects having a vaginal microbiome predictive of pregnancy success after FET. Figure 17 depicts the design of a clinical study. This study mapped the shifts in vaginal microbiomes when 3 sequential administrations of the substantially complete vaginal microbiota preparations to recipients were performed. Recipients were screened to have vaginal dysbiosis based on criteria defined from metagenomic sequencing of a vaginal sample (less than 90% relative abundance of three selected Lactobacillus species – Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii). DETAILED DESCRIPTION The present invention relates to compositions, devices, and kits comprising substantially complete vaginal microbiota preparations (SCVMPs) and methods of making and using the same. Provided herein, in some embodiments, are substantially complete vaginal microbiota preparations (SCVMPs) and compositions for modulation of the vaginal microbiota for treatment of infertility (e.g., in infertile female subjects). In some embodiments, provided herein are compositions for modulation of the vaginal microbiota for treatment of inflammation and/or dysbiosis in infertile female subjects. Further aspects provided herein are substantially complete 20  \\4163‐8733‐4730  v3                vaginal microbiota preparations (SCVMPs) and compositions for modulation of the vaginal microbiota to promote embryo implantation and/or embryo retention, e.g., in female subjects undergoing in vitro fertilization, any other Assisted Reproductive Technology (e.g., intracytoplasmic sperm injection (ICSI)) or fertility-related procedures. The applicant has developed a safe and efficacious process to produce substantially complete vaginal microbiota preparations (SCVMPs) and provides devices and methods for administering and using same, e.g., to restore or maintain a healthy human vaginal microbiota balance in the female genitourinary tract, to treat dysbiosis and/or inflammatory conditions, e.g., in women exhibiting infertility (such as, e.g., women undergoing IVF procedure), thereby treating the infertility and leading to increased pregnancy outcomes. Microbiome in the female reproductive tract The female reproductive tract of placental mammals, including humans, comprises unique structures such as the vagina and the uterus. Distinct bacterial communities exist throughout the female reproductive tract. The vaginal bacterial community is the most well described, however, bacteria have been detected in the upper female reproductive tract as well, forming a continuum of microbiotas changing from the vagina to the ovaries. This continuum may exist despite the barrier properties of cervicovaginal mucus that is capable of “trapping” or slowing the diffusion of microbes or microbe-sized particles through steric and adhesive interactions. This microbial continuity along the reproductive tract (vagina, cervix, uterus, and fallopian tubes) is present in women of reproductive age. A healthy vaginal flora is characterized by an acidic environment inhabited predominantly by lactic acid bacteria, primarily species of Lactobacillus (residing in the vaginal microbial niche). The microbial composition in healthy women can differ, though it is typically dominated by one of four Lactobacillus species: L. crispatus, L. iners, L. gasseri, L. jensenii, and mixtures thereof. A healthy vagina of a women of child-bearing age is estimated to be dominated by 10 7 -10 9 colony forming units of lactic acid producing bacteria (e.g., Lactobacillus) per gram of fluid. The species distribution differs between women of different geographical background, race (e.g., Asian, white women, black, Hispanic), age, lifestyle and the like. The composition of the vaginal flora is also influenced by which specific strains and/or species the woman has inherited from her mother and/or which strains and/or species have migrated from her digestive 21  \\4163‐8733‐4730  v3                tract to the urogenital tract. Healthy, fertile women present with a pH of about 3 to 5.5 (more specifically between pH 3.5 and 4.5) in the vagina, primarily as a result of lactic acid production. Vaginal pH undergoes physiological changes from birth to menopause. The increase of vaginal pH above 4.0-4.5 is detrimental for the survival of Lactobacillus bacteria, but not for other microorganisms. The vaginal lactobacilli are believed to have a protective effect against vaginal colonization by pathogenic microorganisms (e.g., yeast (Candida albicans), Trichomonas vaginalis, Neisseria gonorrhoeae, and Chlamydia trachomatis, and viruses, e.g., HIV, HSV-2, and various anaerobes) and prevent the vaginal establishment of, for instance, bacteria that are present in the colon, such as Gardnerella vaginalis, Mobiluncus, Bacteroides, Prevotella and Escherichia coli. Several factors may contribute to the disturbance of the vaginal flora. Factors may include, a) use of antibiotics to kill pathogenic bacteria which can lead to significantly reduced levels of lactobacilli in the vagina; b) hormonal changes, in particular changes in estrogen levels, which are observed in several phases of a woman's life (e.g., puberty, pregnancy, childbearing age, pre- and post-menopause); estrogen levels are thought to be associated with Lactobacillus levels (dominance) in the vagina; c) sexual intercourse, which can be associated with pH increases (semen generally is alkaline) that may disturb the vaginal flora, because bacteria other than lactobacilli may start to flourish once the vaginal pH increases; d) use of medications, e.g., chemotherapeutics or antimycotics; e) use of birth control products; f) during menstruation; g) insufficient hygiene (e.g., promoting undesirable spread of the microorganisms from rectum to the urogenital area); h) general health status, such as, e.g., being diabetic. Disturbance of the vaginal flora may lead to vaginal dysbiosis and vaginal disorders, e.g., candidiasis and bacterial vaginosis, which are two common vaginal disorders that affect women worldwide. Bacterial vaginosis is believed to be the result of displaced vaginal lactic acid producing bacteria which are replaced by a range of unwanted species such as Gardnerella vaginalis, Bacteroides, Mobiluncus, Prevotella, and Mycoplasma hominis. Vaginal infections are most often associated with one or more of: Escherichia, Enterococcus, Pseudomonas, Proteus, Klebsiella, Streptococcus, Staphylococcus, Gardnerella, Ureaplasma, Bacteroides, Peptococcus, Neisseria, Serratia, Corynebacterium, Clostridium, and Candida. In some embodiments, vaginal dysbiosis is defined as a vaginal microbiome having less than 90% of the detectable bacterial species in a sample of the vaginal microbiome belonging to 22  \\4163‐8733‐4730  v3                the genus Lactobacillus. In some embodiments, a vaginal microbiome is exhibiting dysbiosis if the relative abundance of the combination of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri is less than 90% of the detectable bacterial species in a sample of the vaginal microbiome. In some embodiments, a vaginal microbiome is exhibiting dysbiosis if the relative abundance of bacteria belonging to the genus Lactobacillus is less than 85%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, or 10% of the detectable bacterial species in a sample of the vaginal microbiome. In some embodiments, a vaginal microbiome is exhibiting dysbiosis if the relative abundance of the combination of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri is less than 85%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, or 10% of the detectable bacterial species in a sample of the vaginal microbiome. Vaginal lactobacilli predominance is thought to play an important role in resistance to infection via production of lactic acid and acidification of the vagina and by production of other antimicrobial products, such as, e.g., hydrogen peroxide. The presence of lactobacilli in the vagina has been linked to decreased frequencies of bacterial vaginosis, yeast vaginitis and sexually transmitted pathogens, including Neisseria gonorrhea, Chlamydia trachomatis, and Trichomonas vaginalis. Lactobacillus dominance varies among ethnic groups (they are thought to be very predominant in Asian and white women but less so in black and Hispanic women, though they still represent the majority). Studies have shown that Lactobacillus-depleted communities can be transient, lasting just a few days, while in other instances the depleted communities persist for many weeks. Some women with Lactobacillus-depleted communities remain asymptomatic and healthy. However, such women may be at higher risk for infections and sexually transmitted diseases (STDs), and face challenges getting pregnant, e.g., naturally and/or assisted, e.g., with IVF procedure. In case of IVF, these women often undergo multiple IVF cycles with elevated rates of embryo implantation failures. Immune state and implantation success During regular pregnancy, the fertilized egg is required to successfully implant in the uterine wall of the mother. As part of the implantation process, paternal antigens are expressed by the fetus. These are recognized by the host as foreign and result in the activation of the maternal immune system. Successful pregnancy is thought to require tightly orchestrated 23  \\4163‐8733‐4730  v3                immune interactions between maternal and fetal cells to prevent fetus rejection, while at the same time maintaining effective immune responses in order to protect the mother from harmful pathogens. Several regulatory mechanisms are activated to create a favorable immunological environment for the developing fetus, which can be triggered or suppressed by the microbiota in the vaginal niche of the reproductive tract. It is thought that a successful pregnancy is dependent on the maternal immune system to establish an implantation window by shifting an initial pro-inflammatory response to a tolerogenic state. Initially, pro-inflammatory cytokines and recruited immune cells regulate the adhesive and non-adhesive molecules involved in trophoblast adhesion to the uterine wall, which is the requisite first step of implantation and, subsequently placentation (Marwood et al., Interleukin-11 and leukemia inhibitory factor regulate the adhesion of endometrial epithelial cells: implications in fertility regulation. Endocrinology.150, 2915–2923 (2009); McEwan et al., Cytokine regulation during the formation of the fetal–maternal interface: focus on cell–cell adhesion and remodeling of the extra-cellular matrix. Cytokine Growth Factor Rev.20, 241–249 (2009)). This early inflammation is characterized by an increase in pro-inflammatory cytokines such as, e.g., TNF-α, IL-6, MIP-1β, CX3CL-1, osteopontin, IL-15 and IL-10, secreted by immune and endometrial cells (Boomsma et al., Ovarian stimulation for in vitro fertilization alters the intrauterine cytokine, chemokine, and growth factor milieu encountered by the embryo. Fertil. Steril.94, 1764–1768 (2010); Gnainsky et al., Local injury of the endometrium induces an inflammatory response that promotes successful implantation. Fertil. Steril.94, 2030–2036 (2010); Granot et al., Endometrial inflammation and effect on implantation improvement and pregnancy outcome. Reproduction 144, 661–668 (2012); Van Sinderen et al., Preimplantation human blastocyst‐endometrial interactions: the role of inflammatory mediators. Am. J. Reprod. Immunol.69, 427–440 (2013)). The subsequent transition into an anti-inflammatory and pro- tolerogenic immune environment is characterized by an expansion and recruitment of regulatory T cells (Robertson et al., Immunological determinants of implantation success. Int J Dev Biol (2014) 58(2-4):205–17; Robertson et al., Regulatory T cells in embryo implantation and the immune response to pregnancy. J Clin Invest (2018) 128(10):4224–35; Erlebacher et al., Mechanisms of T cell tolerance towards the allogeneic fetus. Nat Rev Immunol (2013) 13(1):23– 33)). T-regulatory cells interact with dendritic cells and macrophages to promote decidualization of uterine stromal cells, suppress inflammation, and inhibit effector immunity towards fetal 24  \\4163‐8733‐4730  v3                antigens through secretion of IL-10 and TGF-β and a Th-2 anti-inflammatory profile in the endometrium. Uterine natural killer (uNK) cells mediate structural changes in the decidual vasculature that support placental invasion and development. Furthermore, it is thought that uNKs stimulate protolerogenic M2 macrophages and dendritic cells through secretion of IFN-γ and IL-10 (Gonzales et al., Immunogenic Functions Compatible with Pregnancy Progression. PLoS ONE 7(10): e46755 (2012)). It is thought that a Lactobacillus-dominated (healthy) vaginal microbiome may help to modulate the inflammatory response needed for implantation. A dysbiotic microbiome creates a strong pro-inflammatory response which has been shown to be associated with implantation failure. This includes altered antigen presentation and T cell differentiation, proliferation and activation of regulatory cells, as well as the action of hormones, cytokines and other soluble factors. In some embodiments, elevated cervico-vaginal cytokines in dysbiotic vaginal niches comprise one or more of IL-1α, IL-1β, IL-2, IL-5, IL-6, IL-8, IL-12, IL- 15, IL-17, IL-18, IP-10, MCP-1, TNFα, HIF-1α, COX-2 and VEGF. Dysbiosis is also associated with elevated levels of one or more of, e.g., Eotaxin, IL-10, IL-12p40, IL-17, IL-1RA, sIL-2rα, IL-1a, IL-1β, IL-2, IL-6, IP-10, MCP-1, MIP-1α, MIP-1β, TNFα, HIF-1α, COX-2 and VEGF. These biomarkers may be produced in response to inflammation in the vagina which can in turn result from dysbiosis. For example, the cytokine IL-10, which is generally considered to be an anti-inflammatory, regulatory cytokine, can be produced in response to inflammation, e.g., induced by dysbiosis, as a compensatory mechanism. In some embodiments, a healthy vaginal microbiome may be associated with one or more of the cervico-vaginal cytokines IGF-1, IL-4, IL-10, TGFβ and CCL5. The SCVMPs described herein can be used to treat the (local) inflammation (e.g., of the reproductive tract) associated with dysbiosis (dysbiotic microbiota). In some embodiments, no pre-treatment with antibiotics is necessary to substantially revert the dysbiosis (e.g., to healthy) and/or reduce the inflammatory tone in the reproductive tract, which was not previously possible. The preparations provided herein comprise not only a substantially complete (e.g., entire) ecosystem of the vaginal microbiota but also sufficient concentrations/doses and/or amount of the vaginal microbiota in the preparation, and may also, in some embodiments, include additional substances, such as, e.g., one or more (microbial) metabolites of the healthy vaginal niche, and mucus. In some embodiments, the SCVMPs described herein comprises vaginal transudate, mucus (e.g., cervical mucus), and/or vaginal fluid (e.g., vaginal fluid comprising low 25  \\4163‐8733‐4730  v3                protein content and/or vaginal and cervical cells). In some embodiments, vaginal transudate comprises blood, proteins, microbial metabolites, cytokines, low nucleated cell counts, and/or mononuclear cells (e.g., macrophages, lymphocytes and mesothelial cells). The liberal use or overuse of antibiotics is directly associated with the problem of increasing antibiotic resistance. The present preparations, in some embodiments, are not reliant on using antibiotics prior to or during treatment, which is thus a further advancement and advantageous effect. In subjects seeking to undergo IVF procedure that have bacterial vaginosis (BV), a subject may be pretreated with antibiotics in accordance with standard care, which would be prior to administration of the pharmaceutical composition comprising the SCVMP provided herein. In other embodiments, subjects seeking to undergo IVF procedure that have bacterial vaginosis (BV) do not need to be pretreated with antibiotics. Successful colonization and engraftment of the lactobacilli comprised in the SCVMPs may be indicated by one or more of: decreased pH, increased lactic acid content, lower abundance of antibiotic resistance genes, decreased amount of fungal DNA, decreased toxin content, decreased pathogenicity factors, decreased inflammatory cytokines and chemokines, decreased immune cell infiltrates, decreased total bacterial DNA load, decreased total pathogenic DNA load, increased viscoelasticity, increased sialoglycan content, decreased relative or absolute abundance of pathobionts or pathogens, or any combination thereof in the vaginal cavity and the vaginal microbial niche (e.g., when compared to baseline of the same subject (e.g., prior to administration and engraftment) or a non-treated control subject). In some embodiments, the ability of the SCVMP to engraft in a recipient vaginal cavity is influenced by the presence of vaginal transudate, mucus (e.g., cervical mucus), and/or vaginal fluid. In some embodiments, the SCVMP promotes a receptive endometrial lining by affecting a change of the microbiota in the vagina and uterus (e.g., from dysbiotic to healthy), and modulating the inflammation status therein, which in turn increases the chances of successful embryo implantation. In some embodiments, the promotion of a receptive endometrial lining by the SCVMP results in part from the presence of vaginal transudate, mucus (e.g., cervical mucus), and/or vaginal fluid within the SCVMP. Thus, in some embodiments, the SCVMP promotes embryo implantation in a single female subject (e.g., a female subject experiencing infertility and/or undergoing an assisted reproductive procedure (e.g., IVF), intrauterine insemination or treatments to stimulate egg production) or in a population of female subjects. 26  \\4163‐8733‐4730  v3                Embryo implantation may be determined using any method that is known to skilled persons in the field of fertility and reproductive health. The measure of embryo implantation is typically a binary measurement – the embryo either successfully implants into the uterine tract or the embryo does not implant (e.g., no ‘partial’ implantation). In some embodiments, embryo implantation may be measured using a Beta-Human Chorionic Gonadotropin (beta-CG) test (e.g., at two weeks after embryo transfer or conception). In some embodiments, embryo implantation is determined by identifying whether there is at least one gestational sac (e.g., intrauterine gestational sac) at a defined time point (e.g., 5-6 weeks after embryo transfer or conception). In some embodiments, embryo implantation is determined by identifying whether there is a viable pregnancy (e.g., fetal heartbeat present at a defined time point, e.g., 5-6 weeks after embryo transfer or conception). Qualitative and quantitative tests for hCG can measure intact hCG, beta-hCG, or total hCG, which includes all hCG isoforms (e.g., free beta-subunit, free alpha-subunit, nicked hCG, nicked beta-hCG, hCG beta-subunit core fragment). Qualitative urine and serum tests available for home use are based on immunochromatographic technology and are typically designed as lateral flow tests (LFTs). A urine or serum sample travels through a test device through a series of channels or capillaries and interacts with a conjugate pad, which contains labeling particles coated with a first set antibodies specific to hCG. Quantitative measurements of hCG in serum, urine, and plasma can also be obtained by using enzyme-linked immunosorbent assays (ELISAs). A sandwich-ELISA is commonly used for hCG detection. Collected data from such hCG tests can be compared to a standard curve generated from known concentrations of hCG. Typically, hCG levels below 5 mlU/mL indicate no pregnancy, hCG levels between 5 and 25 mlU/ml indicate inconclusive results, and hCG levels above 25 mlU/mL indicate an ongoing pregnancy. In some embodiments, embryo implantation is promoted when the rate of embryo implantation is increased in a population of female subjects being administered the SCVMP relative to a control population. In some embodiments, embryo implantation is promoted when the rate of embryo implantation is increased in a population of female subjects being administered the SCVMP by at least 5%, at least 10%, at least 20%, at least 30%, or at least 50%, relative to a control population. In some embodiments, the rate of embryo implantation is the number of successful embryo implantations (e.g., at 5-6 weeks post-embryo transfer) divided 27  \\4163‐8733‐4730  v3                by the number of embryos transferred. In some embodiments, the rate of embryo implantation is the number of successful embryo implantations divided by the number of eggs (e.g., fertilized or unfertilized) released or placed into the uterus. A control population, for example, may be (i) a population of female subjects (e.g., infertile female subjects) who are not being administered the SCVMP (e.g., and are actively engaged in the same set of fertility treatments, e.g., IVF); (ii) a population of female subjects who are not being administered the SCVMP (e.g., and are actively engaged in unprotected sexual intercourse with a male); (iii) a population of fertile female subjects who are being administered the SCVMP (e.g., and are actively engaged in unprotected sexual intercourse with a male); or (iv) the same population of female subjects being administered the SCVMP during a period of time (e.g., 6 or 12 months) prior to the administration of the preparation. In some embodiments, the rate of embryo implantation is increased in a population of female subjects being administered the SCVMP if one or more of the subjects in the population has at least one successful embryo implantation. For example, the rate of embryo implantation is increased in a population of one hundred female subjects that have been administered the SCVMP if even a single subject has at least one successful embryo implantation. In some embodiments, the rate of embryo implantation is increased in a population of female subjects undergoing a fertility treatment (e.g., an assisted reproductive procedure (e.g., IVF), intrauterine insemination or treatments to stimulate egg production) that is being administered the SCVMP if the rate or number of successful embryo implantations is higher in the population relative to a control population of female subjects undergoing the same fertility treatment and not being administered the SCVMP. For example, the rate of embryo implantation is increased in a population of infertile female subjects undergoing IVF that is being administered the SCVMP if the rate or number of successful embryo implantations is higher in the population relative to a control population of infertile female subjects undergoing IVF and not being administered the SCVMP. In some embodiments, embryo implantation is promoted in a treatment population of female subjects undergoing IVF (e.g., infertile female subjects undergoing IVF) that are being administered the SCVMP if the average number of embryo transfers prior to successful embryo implantation is lower in the treatment population than in a control population (e.g., female 28  \\4163‐8733‐4730  v3                subjects undergoing IVF (e.g., infertile female subjects undergoing IVF) that are not being administered the SCVMP. In some embodiments, embryo retention is promoted when the rate of embryo retention (e.g., ongoing pregnancy) is increased in a population of female subjects being administered the SCVMP relative to a control population. In some embodiments, embryo retention is promoted when the average length of time during which an embryo remains implanted following initial implantation is increased in a population of female subjects being administered the SCVMP by at least 5%, at least 10%, at least 20%, at least 30%, or at least 50%, relative to a control population. In some embodiments, the rate of pregnancy and/or live births is increased in a population of female subjects being administered the SCVMP relative to a control population, e.g., by promoting embryo implantation and/or embryo retention. In some embodiments, the rate of pregnancy is increased in a population of female subjects being administered the SCVMP by at least 5%, at least 10%, at least 20%, at least 30%, or at least 50%, relative to a control population. In some embodiments, the rate of pregnancy in a population refers to the number of successful pregnancies within the population (e.g., number of pregnancies per 1,000 female subjects). In some embodiments, the rate of live births is increased in a population of female subjects being administered the SCVMP by at least 5%, at least 10%, at least 20%, at least 30%, or at least 50%, relative to a control population. In some embodiments, the rate of live births in a population refers to the number of live births (e.g., newborn babies) within the population (e.g., number of live births per 1,000 female subjects). In some embodiments, the number of females determined to have a detectable level of beta hCG hormone (e.g., detected using a pregnancy test) in a population of female subjects being administered the composition is increased relative to a control population. In some embodiments, the rate of clinical pregnancies in a population of female subjects is increased relative to a control population. In some embodiments, the rate of pregnancy losses (e.g., miscarriages) is decreased in a population of female subjects being administered the SCVMP relative to a control population. In some embodiments, the rate of pregnancy losses is decreased in a population of female subjects being administered the SCVMP by at least 5%, at least 10%, at least 20%, at least 30%, or at least 50%, relative to a control population. In some embodiments, the rate of pregnancy losses in a population refers to the number of pregnancy losses within the population (e.g., number of 29  \\4163‐8733‐4730  v3                pregnancy losses per 1,000 female subjects). In some embodiments, the rate of early-term pregnancy loss is reduced in a population of female subjects, wherein an early-term pregnancy loss is a pregnancy loss that occurs 1 day, 2 days, 3 days, up to 1 week, up to 2 weeks, up to 3 weeks, up to 4 weeks, or up to 12 weeks following onset of the pregnancy. In some embodiments, the rate of late-term pregnancy loss is reduced in a population of female subjects, wherein a late-term pregnancy loss is a pregnancy loss that occurs more than 12 weeks following onset of the pregnancy. Vaginal Microbiota and Fertility Treatments In healthy human female subjects, the vaginal, cervical and endometrial microbiota harbor microbiota that is dominated by lactobacilli. Women with a healthy, lactobacilli- dominated vaginal microbiota are thought to have higher success rates for fertility treatments (e.g., in vitro fertilization (IVF), intrauterine insemination or treatments to stimulate egg production) than those with dysbiotic vaginal microbiota (See, e.g., Haahr et al., Abnormal vaginal microbiota may be associated with poor reproductive outcomes: a prospective study in IVF patients. Hum Reprod.2016 Apr;31(4):795-803; Koedooder et al., The vaginal microbiome as a predictor for outcome of in vitro fertilization with or without intracytoplasmic sperm injection: a prospective study. Hum Reprod.2019 Jun 4;34(6):1042-1054; Moreno et al., Endometrial microbiota composition is associated with reproductive outcome in infertile patients. Microbiome.2022 Jan 4;10(1):1). Further, women suffering from bacterial vaginosis (BV) and vaginal dysbiosis have an increased prevalence of diseases or disorders that are associated with inflammation and reduced infertility, such as pelvic inflammatory disease (PID)/endometritis (Wiesenfeld, et al, Lower genital tract infection and endometritis: insight into subclinical pelvic inflammatory disease. Obstet Gynecol.2002 Sep;100(3):456-63; Haggerty, et al, Evaluation and Clinical Health study investigators. Bacterial vaginosis and anaerobic bacteria are associated with endometritis. Clin Infect Dis.2004 Oct 1;39(7):990-5), idiopathic infertility (Campisciano, et al Subclinical alteration of the cervical-vaginal microbiome in women with idiopathic infertility. J Cell Physiol.2017 Jul;232(7):1681-1688; Spandorfer et al., Relationship of abnormal vaginal flora, proinflammatory cytokines and idiopathic infertility in women undergoing IVF. J Reprod Med.2001 Sep;46(9):806-10), secondary infertility (Characterization of the Vaginal Microbiome in Women with Infertility and Its Potential Correlation with 30  \\4163‐8733‐4730  v3                Hormone Stimulation during In vitro Fertilization Surgery. mSystems.2020 Jul 14;5(4):e00450- 20), tubal factor infertility (Wilson, et al, Rates of bacterial vaginosis in women undergoing in vitro fertilisation for different types of infertility. BJOG.2002 Jun;109(6):714-7), endometriosis (Jiang, et al, Intricate Connections between the Microbiota and Endometriosis. Int J Mol Sci. 2021 May 26;22(11):5644; Wei, et al, Microbiota composition and distribution along the female reproductive tract of women with endometriosis. Ann Clin Microbiol Antimicrob.2020 Apr 16;19(1):15; Perrotta, et al, 2020, Reprod Sci),), and polycystic ovary syndrome (PCOS) (Salah, et al, 2012, Eur J Obst & Gyn and Rep Bio). Previous attempts to address dysbiosis and BV in the reproductive tract have largely been unsuccessful. Use of antibiotics does not have lasting effects and treatment shows high rates of dysbiosis (and pathogen) recurrence. Various probiotic products have been suggested and tried. These approaches have had limited success. One major limitation of past approaches has been the use of species typically found in the gut (rhamnosus, acidophilus, reuteri), whereas it was recently demonstrated that in healthy women, typically only 4 species of Lactobacillus (crispatus, iners, gasseri, jensenii) dominate in the human vagina (Gajer et al., 2012; Ravel et al., 2011). One product in development that contains a vaginal-specific Lactobacillus crispatus strain showed only limited therapeutic potential (Hemmerling et al., 2010; Ngugi et al., 2011). The compositions (e.g., the SCVMP) and uses described herein overcome these deficiencies by providing and using pharmaceutical compositions comprising a SCVMP to treat infertility. In some embodiments, the compositions and uses described herein improve the rate of successful pregnancies (e.g., number of clinical pregnancies in a population of female subjects). In some embodiments, the rate of embryonic implantation is increased. In some embodiments, the rate of embryonic retention is increased. In some embodiments, women undergoing IVF procedure (e.g., women with asymptomatic dysbiosis in the reproductive tract) thus require fewer IVF cycles to become pregnant, e.g., compared to women (e.g., women with asymptomatic dysbiosis in the reproductive tract) not receiving the treatments described herein. In some embodiments, the compositions and uses described herein substantially revert a dysbiotic microbiome back to a healthy microbiome. In some embodiments, the compositions and uses described herein substantially decrease a local (e.g., in the reproductive tract) inflammatory tone (e.g., as measured by pro-inflammatory biomarkers). The SCVMP comprises substantially all microbe species that are present in a healthy vaginal or urogenital tract (e.g., the reproductive 31  \\4163‐8733‐4730  v3                tract of a healthy donor). In some embodiments, the pharmaceutical compositions provided herein improve the rate of successful pregnancies, and in particular embryo implantation into the uterine wall, e.g., by reverting vaginal dysbiosis and the associated pro-inflammatory environment which is thought to be detrimental for embryo implantation. Reduction in the inflammatory condition present in the reproductive tract improves the receptivity of the uterus for the embryo. In some embodiments, the compositions (e.g., the SCVMP) and uses described herein increase the chance of successful embryo implantation in a subject undergoing IVF. In some embodiments, the compositions and uses described herein improve the receptivity of the uterus for embryo implantation. In some embodiments, the dysbiotic vaginal, cervical or uterine flora is restored or reverted by replenishing or supplementing the disturbed vaginal, cervical or uterine flora with the SCVMP or a pharmaceutical composition comprising the same described herein. In some embodiments, the SCVMP is administered to the subject about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or about 12 weeks prior to embryo transfer. In some embodiments, the SCVMP is administered to the subject between 1-8 weeks prior to embryo transfer, 2-8 weeks prior to embryo transfer, between 2-12 weeks prior to embryo transfer, 4-12 weeks prior to embryo transfer, 6-12 weeks prior to embryo transfer, or between 6-10 weeks prior to embryo transfer. The subject undergoing fertility treatments (e.g., IVF) may suffer from infertility or sub- fertility. Thus, in some embodiments, the subject undergoing fertility treatments (e.g., IVF) is an infertile female subject. The infertile female subject can be, in some embodiments, any female subject who wants to become pregnant but cannot. In some embodiments, the female subject is a biologically female subject. In some embodiments, an infertile female subject cannot become pregnant because the female subject has been diagnosed to be biologically infertile. In some embodiments, the subject undergoing fertility treatments (e.g., IVF) may have an inflammation-associated infertility condition. An inflammation-associated infertility condition may comprise bacterial vaginosis (BV), pelvic inflammatory disease (PID)/endometritis, tubal factor infertility, endometriosis, or polycystic ovary syndrome (PCOS). In some embodiments, the subject has one or more of the inflammation-associated infertility condition. In some embodiments, the subject has bacterial vaginosis (BV). In some embodiments, the subject has pelvic inflammatory disease (PID). In 32  \\4163‐8733‐4730  v3                some embodiments, the subject has tubal factor infertility. In some embodiments, the subject has endometriosis. In some embodiments, the subject has polycystic ovary syndrome (PCOS). In some embodiments, the subject has idiopathic (unexplained) infertility. In some embodiments, the subject has endometrial infertility, which results from endometriosis. Endometriosis is a chronic inflammatory disease that can cause tissue similar to the lining of the uterus to grow outside of the uterus. In some embodiments, the subject has unexplained infertility, wherein the infertility of the subject cannot be attributed to any particular factor. In some embodiments, the subject has anovulation (i.e., the egg (ovum) of the subject does not release from the subject’s ovary). In some embodiments, the infertile female subject is not biologically infertile. Instead, in such embodiments, the female subject cannot become pregnant because the female subject is not having sexual intercourse with a fertile, biological male subject. In some embodiments, the infertile female subject is having sexual intercourse with a man who has been diagnosed to be biologically infertile. Additionally, in some embodiments, an infertile female subject cannot become pregnant because the female subject is not having sexual intercourse with any men (e.g., because the female subject is abstaining from sex, asexual or a lesbian). In some embodiments, an infertile female subject is having regular unprotected sex with a male subject suffering from a male fertility disorder such as male factor infertility. In some embodiments, an infertile female subject is of an advanced reproductive age (e.g., 35 or older). In some embodiments, an infertile female subject is pre-menopausal. In some embodiments, an infertile female subject has been unable to conceive after 12 months (e.g., after 12, 15, 18, 24, or more months) of unprotected sexual intercourse with one or more men. In some embodiments, an infertile female subject who is less than 35 years of age has been unable to conceive after 12 months (e.g., after 12, 15, 18, 24, or more months) of unprotected sexual intercourse with one or more men. In some embodiments, an infertile female subject has been unable to conceive after 6-12 months (e.g., after 6, 7, 8, 9, 10, or 11 months) of unprotected sexual intercourse with one or more men. In some embodiments, an infertile female subject of an advanced reproductive age (e.g., 35 years or older) has been unable to conceive after 6-12 months (e.g., after 6, 7, 8, 9, 10, or 11 months) of unprotected sexual intercourse with one or more men. 33  \\4163‐8733‐4730  v3                In some embodiments, the subject undergoing fertility treatments (e.g., IVF) is a fertile female subject. A subject who is “undergoing fertility treatments” or “undergoing IVF” may be a subject who is preparing to begin fertility treatments or IVF. For example, a subject exhibiting a dysbiotic microbiota in the genitourinary tract is said to be undergoing IVF if they are administered a SCVMP prior to beginning IVF treatments. A subject in need of a SCVMP as described herein may be an asymptomatic dysbiotic female subject. An asymptomatic dysbiotic female subject is generally described as a subject that has a dysbiotic vaginal microbiome but is not exhibiting symptoms (e.g., clinical symptoms) of bacterial vaginosis or a vaginal infection (e.g., a vaginal yeast infection). Thus, in some embodiments, the dysbiotic vaginal microbiome of an asymptomatic dysbiotic female subject does not comprise detectable or substantial amounts of pathogenic microbes. An asymptomatic dysbiotic female subject may have endometriosis, tubal factor infertility or PCOS. A female subject may be a dysbiotic female subject if less than 90% of the detectable bacterial species in a sample of the vaginal microbiome of the subject belongs to the genus Lactobacillus (e.g., L. crispatus, L. gasseri, and L. jensenii). In some embodiments, the female subject is an asymptomatic dysbiotic female subject, or the population of female subjects is a population of asymptomatic dysbiotic female subjects. The female subject may be 15-34 years of age. In some embodiments, a female subject who is 15-34 years of age has been unable to conceive after 12 months of unprotected sexual intercourse with one or more men. The female subject may be 35-50 years of age or 51-75 years of age. In some embodiments, a female subject who is 34-75 years of age has been unable to conceive after 6 months of unprotected sexual intercourse with one or more men. The female subject may be 15-44 years of age, 35-44 years of age, or 45 or more years of age. The female subject may be 25-37 years of age or 38-45 years of age. In some embodiments, the subject is a pre-menopausal female subject. In some embodiments, the subject is suffering from recurrent implantation failure (RIF). In some embodiments, the female subject (e.g., an infertile female subject) is undergoing an assisted reproductive procedure, or the population of female subjects is a population of subjects undergoing an assisted reproductive procedure. In some embodiments, the assisted reproductive procedure is in vitro fertilization. In some embodiments, the female subject is 34  \\4163‐8733‐4730  v3                undergoing intrauterine insemination or treatments to stimulate egg production, or the population of female subjects is a population of subjects undergoing intrauterine insemination or treatments to stimulate egg production. Pharmaceutical composition comprising a SCVMP Provided are SCVMPs, methods of making and using the same, and pharmaceutical compositions comprising the same. The SCVMPs described herein provide a solution for problems encountered in the past with using isolated and culture-propagated defined or single strain compositions or those containing multiple isolated and culture-propagated strains. Problems include lack of vaginal colonization and engraftment in the urogenital tract, including the vaginal cavity, of the strains that have been administered. The SCVMPs described herein can be, e.g., administered to the vaginal cavity to modulate the vaginal microbial niche for maintenance of a healthy vaginal microbiota and to help restore an unbalanced vaginal microbiota, e.g., a dysbiotic vaginal microbiota. The administration of a SCVMP is preferable and advantageous to composition containing single and culture-propagated strains in that it is capable of efficiently colonizing the vaginal microbial niche upon administration to promote embryo implantation in a subject exhibiting infertility, e.g., in a female subject undergoing in vitro fertilization (IVF). The substantially complete vaginal microbial preparation, in some embodiments, includes bacteria, viruses, fungi, and microbial metabolites. In some embodiments, the substantially complete vaginal microbial composition further comprises mucus, e.g., vaginal or cervicovaginal mucus, and human donor-derived cells and molecules. In some embodiments, one or more of mucus, e.g., cervicovaginal mucus, and human donor-derived cells and molecules is substantially removed. In some embodiments, the substantially complete vaginal microbial preparation is isolated, and thus separated, from the host, e.g., a healthy donor subject. The substantially complete vaginal microbial preparation is obtained from a donor subject, e.g., a healthy donor subject, by collecting the mucosal fluid from the genitourinary tract comprising vaginal or cervicovaginal microbes. Thus, the substantially complete vaginal microbial preparation can be referred to as being donor-derived. In some embodiments, the substantially complete vaginal microbial preparation further comprises the bacteria, fungi/yeasts and phages including their 35  \\4163‐8733‐4730  v3                metabolites and mucus that are found in the genitourinary tract, e.g., the vagina, cervix and/or uterus, of the donor subject. The female urogenital (also known as genital-urinary) tract consists of interconnected biogeographical niches. Bacteria from the vaginal microbial community can migrate through the cervix to remote sites of the urogenital tract. Dysbiosis in the vaginal microbial community can result in dysbiosis in remote sites, including the uterus. Dysbiosis at these sites has been associated with a range of diseases and conditions, including urinary tract infection (UTI), pelvic inflammatory disease (PID), and endometrial receptivity. In some embodiments, endometrial receptivity is a measure of the ability of the embryo to successfully attach to the endometrium. In some embodiments, dysbiosis decreases endometrial receptivity. This can only be achieved after the endometrium underwent a number of histological changes while also increasing in thickness. Dysbiosis has further been associated with a reduced success rate of pregnancy, either natural or assisted (e.g., IVF procedure). For example, it is thought that women with a healthy lactobacilli- dominated vaginal microbiota have significantly increased chances of IVF success than those with dysbiosis. In some embodiments, administration of a SCVMP to the vagina includes resolving dysbiosis in remote sites of the urogenital tract, e.g., in the uterus. In some embodiments, the SCVMPs comprise one, two, three, four or five different bacterial species from the genus Lactobacillus. In some embodiments, the SCVMPs comprise one, two, three, or four different bacterial species from the genus Lactobacillus. In some embodiments, the bacterial species comprise about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, about 99.5%, about 99.9%, 80-99%, 75%-95%, 85%-95%, 85%-99%, or 90%-99% of the preparation (of the total of all detectable bacterial taxa (e.g., species) of the preparation). In some embodiments, the preparation comprises at least one of (a) to (o) Lactobacillus species and species combinations: a) Lactobacillus crispatus; (b) Lactobacillus iners; (c) Lactobacillus jensenii; (d) Lactobacillus gasseri; (e) Lactobacillus crispatus and Lactobacillus iners; (f) Lactobacillus crispatus and Lactobacillus jensenii; (g) Lactobacillus crispatus and Lactobacillus gasseri; (h) Lactobacillus iners and Lactobacillus jensenii; (i) Lactobacillus iners and Lactobacillus gasseri; (j) Lactobacillus jensenii and Lactobacillus gasseri; (k) Lactobacillus crispatus, Lactobacillus iners and Lactobacillus jensenii; (l) Lactobacillus crispatus, 36  \\4163‐8733‐4730  v3                Lactobacillus iners and Lactobacillus gasseri; (m) Lactobacillus crispatus, Lactobacillus jensenii and Lactobacillus gasseri; (n) Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri; (o) Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri. In one aspect, the SCVMP (i) comprises one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) comprises less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier or diluent. In some embodiments, the SCVMP comprises one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 90- 99.9% of all detectable bacterial species of the preparation. In some embodiments, the SCVMP comprises one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of all detectable bacterial species of the preparation. In some embodiments, the SCVMP (i) comprises one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) comprises less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier or diluent. In some embodiments, the SCVMP comprises one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 90-99.9% of all detectable bacterial species of the preparation. In some embodiments, the SCVMP comprises one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri, which comprise at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of all detectable bacterial species of the preparation. 37  \\4163‐8733‐4730  v3                In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise one bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus crispatus. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus iners. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus jensenii. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus gasseri. In some embodiments, about 90-99.9% of all detectable bacterial species of the preparation comprise one bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, about 90-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus crispatus. In some embodiments, about 90-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus jensenii. In some embodiments, about 90- 99.9% of all detectable bacterial species of the preparation comprise Lactobacillus gasseri. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise two bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus crispatus and Lactobacillus iners. In some embodiments, about 80- 99.9% of all detectable bacterial species of the preparation comprise Lactobacillus crispatus and Lactobacillus jensenii. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus crispatus and Lactobacillus gasseri. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus iners and Lactobacillus jensenii. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus iners and Lactobacillus gasseri. In some embodiments, about 90-99.9% of all detectable bacterial species of the preparation comprise two bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, about 90-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus crispatus and Lactobacillus jensenii. In some embodiments, about 90-99.9% of all 38  \\4163‐8733‐4730  v3                detectable bacterial species of the preparation comprise Lactobacillus crispatus and Lactobacillus gasseri. In some embodiments, about 90-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus jensenii and Lactobacillus gasseri. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus crispatus, Lactobacillus iners and jensenii. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus crispatus, Lactobacillus iners and gasseri. In some embodiments, about 90-99.9% of all detectable bacterial species of the preparation comprise Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of all detectable bacterial species of the preparation are Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri. In some embodiments, about 80-99.9% of all detectable bacterial species of the preparation comprise four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, Lactobacillus crispatus or Lactobacillus iners are present in greater relative quantities than other bacterial species of the preparation, for example, 80-99.9% of all detectable bacterial species of the SCVMP may be Lactobacillus crispatus, further comprising less than 20%, 10%, 5%, 2%, 1%, 0.5% or 0.1% other bacterial species. Further Lactobacillus species In some embodiments, one or more additional Lactobacillus species are present in the preparations in minor quantities (e.g., less than 20%, 15%, 10%, 5%, 2%, 1% of the Lactobacillus species of the preparation). In some embodiments, these lactobacilli species are present in a concentration of about 0.01 – 1%, 0.02 – 0.5% or 0.01 – 0.3% of all detectable bacterial species of a SCVMP. 39  \\4163‐8733‐4730  v3                In a further embodiment, the SCVMP comprises further lactobacilli other than Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, or Lactobacillus gasseri, wherein the further Lactobacillus species include, e.g., Lactobacillus acidophilus, Limosilactobacillus fermentum (formerly known as Lactobacillus fermentum), Lacticaseibacillus casei (formerly known as Lactobacillus casei), and Lacticaseibacillus rhamnosus (formerly known as Lactobacillus rhamnosus). As used herein, Limosilactobacillus fermentum, Lacticaseibacillus casei, Lacticaseibacillus rhamnosus are referred to as Lactobacillus and are included in the meaning of Lactobacillus. The SCVMP comprises less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, SCVMP of the invention comprises less than 10%, less than 7%, less than 5%, less than 2%, less than 1%, less than 0.5%, or less than 0.1% of Gardnerella spp., Atopobium spp., and Prevotella spp.. The preparation can further comprise less than 5% of Gardnerella vaginalis., Atopobium spp., and Prevotella spp. and Fannyhessa vaginae. Gardnerella vaginalis was historically misclassified and has recently been re-classified as belonging to the genus Bifidobacteria. The terms Gardnerella vaginalis and Bifidobacterium vaginalis are thus used interchangeably. Atopobium vaginae and Fannyhessea vaginea are also used interchangeably throughout the application. Provided herein are SCVMPs, which are separate from the animal or human body (isolated SCVMPs). The SCVMP is thus used interchangeably with isolated SCVMP. Lactobacillus crispatus-dominant preparations Provided herein are Lactobacillus crispatus-dominant SCVMPs, wherein Lactobacillus crispatus is present in a greater amount than each of Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri. Preferred aspects and embodiments of Lactobacillus crispatus- dominant SCVMPs are provided in the following. In one aspect, the SCVMP of the invention comprises Lactobacillus crispatus, in a relative quantity of about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, preparation comprises Lactobacillus crispatus, in a relative quantity of above 90%, 95%, 99% or 99.9% of all detectable bacterial species of the preparation. In some embodiments, the species 40  \\4163‐8733‐4730  v3                Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri are not present in detectable quantities in the preparation. In another aspect, the SCVMP of the invention comprises Lactobacillus crispatus and Lactobacillus iners, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus gasseri and/or Lactobacillus jensenii. In some embodiments, the preparation comprises Lactobacillus crispatus and Lactobacillus iners which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises up to 5%, 10%, 20% or 30% of all detectable bacterial species of the preparation. In some embodiments, the preparation of the invention comprises Lactobacillus crispatus and Lactobacillus iners which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises about 5-40%, such as 5-10%, 10-20%, 20-30%, or 30-40% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus and Lactobacillus iners which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 5%, 10%, 20% or 30% of all detectable bacterial species of the preparation. In one aspect, the SCVMP of the invention comprises Lactobacillus crispatus and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus gasseri and/or Lactobacillus iners. In some embodiments, the preparation comprises Lactobacillus crispatus and Lactobacillus jensenii, which together comprise about 80- 99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus jensenii comprises at least 0.01 to about 45% of all detectable bacterial species of the preparation. In some embodiments, the preparation of the invention comprises Lactobacillus crispatus and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus jensenii comprises about 0.01-5%, 5-10%, 10- 20%, or 30-40% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus and Lactobacillus jensenii which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein 41  \\4163‐8733‐4730  v3                Lactobacillus jensenii comprises about 0.01-5% of all detectable bacterial species of the preparation. In one aspect, the SCVMP of the invention comprises Lactobacillus crispatus, Lactobacillus iners and Lactobacillus jensenii which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus gasseri. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus iners and Lactobacillus jensenii comprises at least 0.01 to about 20% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus iners and Lactobacillus jensenii comprises at least 0.01 to about 15% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus iners and Lactobacillus jensenii comprises about 2-15% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80- 99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus iners and Lactobacillus jensenii comprises about 2-10% of all detectable bacterial species of the preparation. In some embodiments, the preparation of the invention comprises Lactobacillus crispatus, Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80- 99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus jensenii comprises about 0.01-5%, 5-10%, or 10-20% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises about 0.01-5%, 5-10%, or 10-20% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus Lactobacillus iners and 42  \\4163‐8733‐4730  v3                Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus iners and Lactobacillus jensenii comprises up to 15% of all detectable bacterial species. In one aspect, the SCVMP of the invention comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus crispatus comprise at least 50%, 60%, 70% or 80% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus jensenii, Lactobacillus iners and Lactobacillus gasseri comprises 0.01-20%, 0.2-15% or 0.2-10% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus jensenii, Lactobacillus iners and Lactobacillus gasseri comprises 0.01 to about 5% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus crispatus comprises at least 60% of all detectable bacterial species of the preparation, and further wherein each of Lactobacillus jensenii, Lactobacillus crispatus and Lactobacillus gasseri comprises 0.01 to about 10% of all detectable bacterial species of the preparation. Lactobacillus iners-dominant preparations The invention further provides Lactobacillus iners-dominant SCVMPs, wherein Lactobacillus iners is present in a greater amount than each of Lactobacillus crispatus, 43  \\4163‐8733‐4730  v3                Lactobacillus jensenii and Lactobacillus gasseri. Preferred aspects and embodiments of Lactobacillus iners-dominant SCVMPs are provided in the following. In one aspect, the SCVMP of the invention comprises Lactobacillus iners, in a relative quantity of about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, preparation comprises Lactobacillus iners, in a relative quantity of above 90%, 95%, 99% or 99.9% of all detectable bacterial species of the preparation. In some embodiments, the species Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri are not present in detectable quantities in the preparation. In another aspect, the SCVMP of the invention comprises Lactobacillus iners and Lactobacillus crispatus, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus gasseri. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus crispatus, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus crispatus comprises less than 20%, less than 10% or less than 5% of all detectable bacterial species of the preparation. In some embodiments, the preparation of the invention comprises Lactobacillus iners and Lactobacillus crispatus, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus crispatus comprises 0.01-10%, 0.01-5%, 0.01-2% or 0.01-1%, of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus crispatus, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 50%, 60%, 70%, 80%, 90%, 95%, or 99% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus crispatus, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 70% and Lactobacillus crispatus comprises less than 20% of all detectable bacterial species of the preparation. In another aspect, the SCVMP of the invention comprises Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella 44  \\4163‐8733‐4730  v3                spp.. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus gasseri and/or Lactobacillus crispatus. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80- 99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus jensenii comprises less than 1%, 0.5%, 0.2%, 0.1%, 0.05% or 0.01% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus jensenii comprises 0.01 – 0.05% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 70% and Lactobacillus jensenii comprises less than 1% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 80% and Lactobacillus jensenii comprises less than 0.1% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 90% and Lactobacillus jensenii comprises less than 0.1% of all detectable bacterial species of the preparation. In another aspect, the SCVMP of the invention comprises Lactobacillus iners and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus jensenii and/or Lactobacillus crispatus. In some embodiments, Lactobacillus jensenii and/or Lactobacillus crispatus comprise less than 2%, 1%, 0.5%, 0.1% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus gasseri comprises less than 5%, 4%, 3%, 2%, or 1% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus gasseri, which 45  \\4163‐8733‐4730  v3                together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus gasseri comprises 0.01-5%, 1-4%, or 1-3% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 70% and Lactobacillus gasseri comprises less than 5% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 80% and Lactobacillus gasseri comprises less than 5% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners and Lactobacillus gasseri, which together comprise about 80- 99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 90% and Lactobacillus gasseri comprises less than 5% of all detectable bacterial species of the preparation. In one aspect, the SCVMP of the invention comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus gasseri. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus crispatus and Lactobacillus jensenii comprises at least 0.01 to about 10% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus crispatus and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus crispatus and Lactobacillus jensenii comprises at least 0.01 to about 5% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus crispatus and Lactobacillus jensenii comprises about 0.01-1% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus 46  \\4163‐8733‐4730  v3                crispatus and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus jensenii comprises less than 2%, 1%, 0.5%, 0.2% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus crispatus comprises less than 2%, 1%, 0.5%, 0.2% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus iners and Lactobacillus jensenii comprises less than 2%, 1%, 0.5%, 0.2% of all detectable bacterial species in the preparation. In one aspect, the SCVMP of the invention comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus jensenii. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus crispatus and Lactobacillus gasseri comprises at least 0.01 to about 10% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus crispatus and Lactobacillus gasseri comprises at least 0.01 to about 5% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus crispatus and Lactobacillus gasseri comprises about 0.01-1% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus gasseri comprises less than 2%, 1%, 0.5%, 0.2% of all detectable bacterial species of the preparation. In some embodiments, the 47  \\4163‐8733‐4730  v3                preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus crispatus comprises less than 2%, 1%, 0.5%, 0.2% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus iners, Lactobacillus crispatus and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus iners and Lactobacillus gasseri comprises less than 2%, 1%, 0.5%, 0.2% of all detectable bacterial species in the preparation. In one aspect, the SCVMP of the invention comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 50%, 60%, 70% or 80% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus jensenii, Lactobacillus iners and Lactobacillus gasseri comprises 0.01-25%, 0.1-20% or 0.2-15% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein each of Lactobacillus jensenii, Lactobacillus crispatus and Lactobacillus gasseri comprises 0.01 to about 5% of all detectable bacterial species of the preparation. In some embodiments, the preparation comprises Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii and Lactobacillus gasseri, which together comprise about 80-99.9% of all detectable bacterial species of the preparation, wherein Lactobacillus iners comprises at least 50% of all detectable bacterial species of the preparation, and further wherein each of Lactobacillus jensenii, Lactobacillus crispatus and Lactobacillus gasseri comprises 0.01 to about 25% of all detectable bacterial species of the preparation. 48  \\4163‐8733‐4730  v3                Lactobacillus jensenii-dominant preparations The invention further provides Lactobacillus jensenii-dominant substantially complete vaginal microbiota preparations, wherein Lactobacillus jensenii is present in a greater amount than each of Lactobacillus crispatus, Lactobacillus iners and Lactobacillus gasseri. Preferred aspects and embodiments of Lactobacillus jensenii-dominant substantially complete vaginal microbiota preparations are provided in the following. In one aspect, the SCVMP of the invention comprises Lactobacillus jensenii, Lactobacillus crispatus, Lactobacillus iners and Lactobacillus gasseri in a relative quantity of about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, preparation comprises Lactobacillus jensenii in a relative quantity of above 60%, 65%, 70% or 75% of all detectable bacterial species of the preparation. In some embodiments, each of Lactobacillus crispatus, Lactobacillus iners, Lactobacillus gasseri comprises 0.01 to about 20% of all detectable bacterial species of the preparation. In some embodiments, each of Lactobacillus crispatus, Lactobacillus iners, Lactobacillus gasseri comprises 0.05 to about 15% of all detectable bacterial species of the preparation. In some embodiments, Lactobacillus jensenii comprises at least 65% of all detectable bacterial species of the preparation, and further wherein each of Lactobacillus crispatus, Lactobacillus iners, Lactobacillus gasseri comprises 0.01 to about 15% of all detectable bacterial species of the preparation. Lactobacillus gasseri-dominant preparations The invention further provides Lactobacillus gasseri-dominant substantially complete vaginal microbiota preparations, wherein Lactobacillus gasseri is present in a greater amount than each of Lactobacillus crispatus, Lactobacillus jensenii and Lactobacillus gasseri. Preferred aspects and embodiments of Lactobacillus gasseri-dominant substantially complete vaginal microbiota preparations are provided in the following. In one aspect, the SCVMP of the invention comprises Lactobacillus gasseri, in a relative quantity of about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, preparation comprises Lactobacillus gasseri, in a relative quantity of above 90%, 95%, 99% or 99.9% of all 49  \\4163‐8733‐4730  v3                detectable bacterial species of the preparation. In some embodiments, the species Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri are not present in detectable quantities in the preparation. In another aspect, the SCVMP of the invention comprises Lactobacillus gasseri, Lactobacillus crispatus, Lactobacillus iners and/or Lactobacillus jensenii, which together comprise about 80-99.9% of all detectable bacterial species of the preparation; and less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus iners and/or Lactobacillus jensenii. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus crispatus and/or Lactobacillus jensenii. In some embodiments, the preparation does not comprise detectable quantities of Lactobacillus iners and/or Lactobacillus crispatus. In some embodiments, the preparation comprises Lactobacillus gasseri in a relative quantity of at least 40%, 45%, 50%, 55%, 60%, 65% or more of all detectable bacterial species of the preparation. The SCVMP, and pharmaceutical composition comprising the same, are suitable for administration, preferably vaginal administration, to a subject. The subject can be a human. In one aspect, the SCVMP provided herein is suitable for vaginal administration. In a further aspect, the SCVMP provided herein is for use in treating inflammation or a disorder associated with inflammation. In a further aspect, the SCVMP provided herein comprises an effective amount of vaginal lactobacilli for engrafting in a recipient´s vaginal niche and treating inflammation. Lactobacilli in the vaginal niche Lactobacilli are the predominant microorganisms in the healthy vaginal microbial community and they play a major role in maintaining a healthy urogenital tract. Lactobacilli are capable of preventing adhesion and growth of pathogenic microorganisms and/or overgrowth of pathobionts through mechanisms that appear to involve secretion of anti-adhesion factors, hydrogen peroxide, bacteriocins and fermenting the glycogen to lactic acid, thereby creating an acidic environment hostile to pathogens and pathobionts. The genus Lactobacillus comprises a phenotypically heterogenous group of Gram-positive, aerotolerant anaerobic, lactic acid producing bacteria. Other typical characteristics include being catalase-negative and rod-shaped, and generally possess DNA with a low content of guanine (G) and cytosine (C), less than about 50  \\4163‐8733‐4730  v3                50%. They are members of the phylum Firmicutes, class Bacilli, order Lactobacillales and family Lactobacillaceae. One skilled in the art will be able to identify Lactobacillus species using standard techniques. Species of lactobacilli can be identified phenotypically, as well as genetically, e.g., on the basis of 16S rRNA (ribosomal RNA) sequence (or the DNA encoding the 16S rRNA, generally referred to as 16S rDNA). Genetic analysis can be performed using standard techniques, for example whole genome sequencing analysis as well as widely used typing approaches based on nucleotide variation in several hundred DNA sequences and a few gene fragments: Multi-locus Sequence Typing (MLST), Multi-locus Variable number of tandem repeats Analysis (MLVA), rMLST and cgMLST) discussed, e.g., in Marcos Pérez-Losada, M. et al., “Microbial sequence typing in the genomic era”, Infection, Genetics and Evolution, Vol.63, Sep.2018, p.346-359. Other identification techniques include: Vaginal pH, Nugent Score, Whiff Test, gas liquid chromatographic analysis of glucose fermentation products, total anaerobe concentrations, total aerobe concentrations, enzymatic activity (e.g., lipase, phospholipase A2 and phospholipase C, hydrogen peroxide production). In some embodiments, the SCVMPs described herein do not comprise (and are not derived from) isolated and/or culture-propagated bacterial strain(s). SCVMPs can be prepared from cervicovaginal secretions (vaginal fluid), e.g., collected from the vaginal tract of a female donor with a healthy vaginal flora. SCVMPs can be collected using standard techniques using commercially available collection devices, such as, a menstrual fluid collection device (soft cup or soft disc), a syringe, a tube, spatula or beaker, or an absorbent matrix. In some embodiments, the menstrual fluid collection device is a vaginal self-sampling device. A vaginal self-sampling device can be, e.g., used by donors to collect vaginal fluid or cervicovaginal secretions without the help of another person. Optionally, the collected material is undergoing centrifugation. The centrifugation step may be performed to facilitate collection, without physical separation of vaginal fluid components. In some embodiments, the SCVMPs comprise one or more of: mucus (e.g., secreted by the cervix), shed epithelial cells, vaginal transudate, and bacteria other than lactobacilli found in the secretion from the female donor. It is thought that mucus and other components of the secretion (including other bacteria) are beneficial to Lactobacillus growth and survival upon administration to the urogenital tract thereby supporting engraftment in a female recipient. This 51  \\4163‐8733‐4730  v3                provides an advantage over compositions comprising isolated strain(s). Thus, in some embodiments, the SCVMP is not cultured (e.g., for the purpose of strain isolation) or propagated in vitro but rather preferably stored in the refrigerator at 4°C or immediately frozen after collection (e.g., frozen to 0℃, -20℃, -80℃, -190℃), or optionally spray dried or lyophilized. If desired, the cervicovaginal secretions can be further processed, e.g., prior to refrigeration or freezing, e.g., by filtration for sterility and/or to remove residual particles, aggregates and cells, and adding diluent, e.g., to arrive at a desired volume, concentration (e.g., CFU/mL) and/or viscosity, as discussed herein. Optionally, the SCVMP is kept refrigerated or frozen until it is formulated into a dosage form and/or dispensed into an applicator or dispenser. Other advantages of the SCVMPs described herein include that, In some embodiments, substantial engraftment does not require the use of mucus adhesive excipients (such as, e.g., hydrocolloids, e.g., xanthan gum, locust bean gum alginate) to increase the ability to colonize by adherence of lactobacilli to the mucosal membrane, which is sometimes used to increase engraftment of isolated, propagated strains. This minimizes the risk of triggering an adverse side effect, such as an allergic reaction due to the mucus adhesive excipient, and increases tolerance. Another advantage of the SCVMPs described herein is the efficient and prolonged engrafting/colonization of the lactobacilli in the vaginal mucosa. In some embodiments, the colonization effect persists for at least 1, 2, 3, 4, 5 or more menstrual cycles after administration of the SCVMP. In some embodiments, the lactobacilli delivered from the SCVMP remains engrafted for at least 1, 2, 3, 4, 5 or more menstrual cycles after administration of the SCVMP. In some embodiments, the colonization effect persists for at least 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 18 months, 24 months or longer after administration of the SCVMP. In some embodiments, the lactobacilli delivered from the SCVMP remains engrafted for at least 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 18 months, 24 months or longer after administration of the SCVMP. Engraftment can be determined, e.g., by methods described herein. Some Composition Characteristics Provided herein are compositions, such as pharmaceutical compositions comprising the SCVMPs. In some embodiments, the pharmaceutical compositions comprise i) a SCVMP comprising, e.g., one or more Lactobacillus species and optionally one or more residual 52  \\4163‐8733‐4730  v3                constituents of a cervicovaginal secretion (such as, e.g., vaginal mucus, vaginal transudate, other vaginal fluids, and vaginal epithelial cells), ii) a pharmaceutically acceptable buffer or diluent or other excipients, such as, e.g., saline (e.g., to adjust the viscosity and/or isotonicity/osmolarity of the composition), iii) one or more acidifying agents, e.g., lactic acid or boric acid (e.g., to adjust the pH of the composition, e.g., to below pH 5, or between pH 3.0 and 4.5), iv) one or more other active agents, such as, e.g., prebiotics (e.g., to generate a symbiotic mixture with the SCVMP), spermicides (e.g., to kill or inactivate residual sperm in the preparation); hormonal agents (e.g., estrogen), anti-inflammatory agents, and the like. In preferred embodiments, the pharmaceutical compositions comprise (i) and (ii). In one embodiment, the pharmaceutical compositions consist of (i) and (ii). In one embodiment, the pharmaceutical compositions comprise (i) and (ii) but not (iii) and (iv). In one embodiment, the pharmaceutical compositions comprise (i), (ii), and (iii) but not (iv). In one embodiment, the pharmaceutical compositions comprise (i), (ii), (iii) and a spermicide. In some embodiment, the pharmaceutical compositions do not comprise prebiotics, hormonal or anti-inflammatory agents. Adjuvant, excipient and other agents The compositions comprising a SCVMP described herein may optionally comprise one or more adjuvants, excipient or agents, including but not limited to acidifying agents, pharmaceutically acceptable buffers or diluents (e.g., saline (e.g., 0.9% NaCl)), spermicides, prebiotics or other agents. Acidifying Agents Acidifying agents may comprise, e.g., organic acids or salts thereof. In some embodiments, acidifying agents may be used to reduce the pH of the compositions, e.g., to below pH 5.5 or 5.0, e.g., to between pH 3.5 to 4.5, or pH 3.0 to 4.5. In decreasing pH such acidifiers may act as anti-microbial agents (e.g., to inhibit Candida or pathogenic bacteria). Acidifying agents comprise, e.g., lactic, acetic, ascorbic, citric, folic sorbic, or boric acid. In other embodiments, the acidifying agent is administered separate from the compositions comprising a SCVMP; e.g. prior to, concurrent with, or after administration of the composition (e.g., in a different dosage form, such as, e.g. a suppository, cream, gel, powder, douche or similar), e.g., for one to seven days, or one to ten days. In these embodiments, the acidifying agent may be 53  \\4163‐8733‐4730  v3                used to promote the survival and engraftment of the lactobacilli comprised in the SCVMP. Acidifying agents may also be useful as spermicides, e.g., to kill or inactivate residual sperm that may be present in the preparation. In one embodiment, the spermicidal activity is contributed by adding lactic acid. In one embodiment, lactic acid may be provided as a racemic mixture of D- and L-isomers, or at different suitable ratio, including, e.g., only D-lactate or only L-lactate. In some embodiments, the compositions comprising a SCVMP is acidified by adding 0.1%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3% or 5% of acidifier (e.g., lactic acid). In preferred embodiments, the acidifier is added at a concentration of 0.5% to 1.5%, or 0.2% to 2% (w/w), or a similar concentration that matches a healthy vagina. Viscosity The compositions comprising a SCVMP described herein may comprise one or more pharmaceutically acceptable buffer or diluent or other excipients. In preferred embodiments, the diluent is saline (e.g., 0.9% NaCl), e.g., sterile normal saline. In one embodiment, the diluent is used to adjust the viscosity of the composition, e.g., to lower the viscosity of the SCVMP derived from the cervicovaginal secretion, thereby increasing the ability to administer the composition to a female recipient, e.g., using an applicator or dispenser or similar vaginal delivery system. In other embodiments, one or more excipients is used to formulate the composition in different dosage forms, such as, e.g., suppositories, creams or dissolving films or tablets. In some embodiments, the dosage form is liquid, solid or semi-solid. The solid dosage form preferably comprises a tablet, capsule, or a film. The semi-solid dosage form preferably comprises a suppository, ointment, gel, cream or rigid foam. In a preferred embodiment, the dosage form is a gel. When adjusting the viscosity for administration to a female recipient’s vaginal cavity, e.g., using an applicator or dispenser, care should be taken to adjust the viscosity to be easily dispensable in the vaginal cavity (e.g., without having to apply significant force to expel the liquid composition), yet avoid making the composition so fluid/liquid that is does not stay in the vaginal cavity for any appreciable amount of time after administration. Thus, a viscosity should be selected that is suitable to prevent rapid discharge from the vaginal cavity. The compositions comprising a SCVMP described herein are preferably of a viscosity which allows the majority of it to stay in the vagina for at least 5 minutes, at least 10 minutes, at least 20 minutes, at least 30 54  \\4163‐8733‐4730  v3                minutes, when the female recipient is in an upright position, although administration is preferably carried out in a lithotomy position, e.g., with the female recipient lying down. Viscosity can be measured, e.g., using a Viscometer. Spermicides The compositions comprising a SCVMP described herein may comprise one or more spermicides. Care should be taken when using nonoxynol-9 (N-9) because of its membrane disruptive properties (it increases the permeability of vaginal tissue by causing damage the cervicovaginal epithelium) and has been shown to be detrimental to Lactobacillus spp. Other spermicides include octoxynol-9, sodium cholate, and benzalkonium chloride. In one embodiment, lactic acid is used. In other embodiments, lactic acid may be used in combination, e.g., with citric acid. Prebiotics A “prebiotic” as used herein is a growth substrate, which increases growth of bacteria (such as lactobacilli) comprised in the SCVMPs, as could be measured, e.g., in vitro. If desired, though it is not generally necessary, a prebiotic may be added to the compositions described herein, e.g., to create a synbiotic mixture, e.g., to increase growth of the bacteria comprised in the SCVMPs upon administration to the genitourinary tract of a female recipient. This may, under certain circumstances, increase successful colonization and engraftment. In other embodiments, prebiotics may be used for the maintenance of an engrafted preparation and/or general vaginal health. If a prebiotic is desired, it should be carefully chosen to not be greatly metabolizable by any yeast (e.g., Candida species), pathobionts or pathogens (e.g., E. coli and other Gram- negative bacteria) that may reside in the female recipient’s genitourinary tract (e.g., to avoid promoting their growth). Prebiotics include, e.g., lactitol, lactulose, and in some instances also other oligosaccharides and soluble fibers, e.g., fructooligosaccharides (FOS), glucooligosaccharides (GOS), and inulin. 55  \\4163‐8733‐4730  v3                Other active agents If desired, other active agents may be added to the compositions described herein, e.g., to address bacterial or fungal infections and/or sexually transmitted diseases in the recipient female, for example antimicrobial agents, antifungal agents, antibacterial agents, antiviral agents, antibiotics, antiparasitic agents (e.g., with activities against Trichomonas vaginalis), anti- inflammatory agents, and the like. Care must be taken when formulating these agents into the pharmaceutical composition so as to not substantially interfere with the activity and efficacy of the SCVMPs (and lactobacilli) comprised in the compositions. In some embodiments, the pharmaceutical compositions comprise a form of estrogen. Adequate levels of estrogens play a role in the trophism of vaginal mucosa, and estrogens increase the cellular content of glycogen. In some embodiments, the pharmaceutical compositions comprise thiosulfate, e.g., to potentiate the anti-pathogenic effect of lactobacilli. If desired, the pharmaceutical compositions can further contain an antibiotic, such as, e.g., metronidazole, or one or more antibiotics of the following classes: a macrolide (e.g., azithromycin, clarithromycin and erythromycin), a tetracycline (e.g., doxycycline, tigecycline), a fluoroquinolone (e.g., gemifloxacin, levofloxacin, ciprofloxacin and mocifloxacin), a cephalosporin (e.g., ceftriaxone, defotaxime, ceftazidime, cefepime), a penicillin (e.g., amoxicillin, amoxicillin with clavulanate, ampicillin, piperacillin, and ticarcillin) optionally with a beta-lactamase inhibitor (e.g., sulbactam, tazobactam and clavulanic acid), such as ampicillin- sulbactam, piperacillin-tazobactam and ticarcillin with clavulanate, an aminoglycoside (e.g., amikacin, arbekacin, gentamicin, kanamycin, neomycin, netilmicin, paromomycin, rhodostreptomycin, streptomycin, tobramycin, and apramycin), a penem or carbapenem (e.g. doripenem, ertapenem, imipenem and meropenem), a monobactam (e.g., aztreonam), an oxazolidinone (e.g., linezolid), vancomycin, glycopeptide antibiotics (e.g. telavancin), and the like. In some embodiments, the pharmaceutical compositions can further contain an antimicrobial (an antibiotic or antifungal) selected from metronidazole, tinidazole, secnidazole, clindamycin, nystatin, azithromycin, erythromycin, ofloxacin, doxycycline, levofloxacin, amoxicillin, and fluconazole. 56  \\4163‐8733‐4730  v3                If desired, the pharmaceutical composition can contain an agent for treating infections with mycobacteria. Suitable agents for treating infections with mycobacteria include an aminoglycoside (e.g., capreomycin, kanamycin, streptomycin), a fluoroquinolone (e.g. ciprofloxacin, levofloxacin, moxifloxacin), isozianid and isozianid analogs (e.g. ethionamide), aminosalicylate, cycloserine, diarylquinoline, ethambutol, pyrazinamide, protionamide, rifampin, and the like. If desired, the pharmaceutical composition can contain a suitable antiviral agent, such as remdesivir, oseltamivir, zanamavir, amantidine or rimantadine, ribavirin, gancyclovir, valgancyclovir, foscavir, Cytogam® (cytomegalovirus immune globulin), pleconaril, rupintrivir, palivizumab, motavizumab, cytarabine, docosanol, denotivir, cidofovir, and acyclovir. If desired, the pharmaceutical composition can contain a suitable antifungal agent, such as polyene (e.g., nystatin and natamycin) and imidazole antifungals (e.g., flucanozole and clotrimazole). If desired, the pharmaceutical composition can contain one or more suitable steroids. For example, the composition may include androgens/anabolic steroids, estrogens, progestogens, corticosteroids, neurosteroids, estradiol, estropipate, premarin, drospirenone, noresthisterone, levonorgestrel, testosterone, fluoxymesterone, methylesterosterone, oxandrolone, and oxymetholone. Combination Therapies Provided herein are methods to treat a female subject, e.g., a human female, in need thereof, e.g., a subject exhibiting dysbiosis (e.g., dysbiosis in the urogenital tract and being sub- fertile or infertile), by administering an effective amount of a composition, such as a pharmaceutical composition comprising a SCVMP described herein. It will be understood by one of skill in the art that the administration regimen for treating may include one or more other therapies in combination with the administration of the SCVMPs and compositions described herein. In some embodiments, the methods for treating vaginal dysbiosis described herein may further comprise administering standard of care treatment. For example, the methods for treating vaginal dysbiosis described herein may further comprise administering antimicrobial agents, antifungal agents, antibacterial agents, antiviral agents, antibiotics, antiparasitic agents (e.g., with activities against Trichomonas vaginalis), anti- 57  \\4163‐8733‐4730  v3                inflammatory agents, and the like. Current standard of care antimicrobials (antibiotics, antifungals) include metronidazole, tinidazole, secnidazole, clindamycin, nystatin, azithromycin, erythromycin, ofloxacin, doxycycline, levofloxacin, amoxicillin, and fluconazole. In another example, the methods for treating vaginal dysbiosis described herein may further comprise administering thiosulfate, e.g., to help recolonize the vaginal microbiota and to prevent the regrowth of pathogenic agents and thus recurrences. Any of the therapeutic agents described herein can be considered a) for formulation as a pharmaceutical composition with the SCVMPs, or b) as a combination therapy. These combination therapies may be administered together or separately from and concurrent with (substantially the same time) or sequentially to (e.g., prior to or after) administration of the SCVMPs and compositions described herein. They may be administered using different routes of administration and dosage forms, such as orally (e.g., as a pill) or topical (e.g., as a gel). The use combination therapies should be assessed to determine that the treatment does not substantially interfere with the activity and efficacy of the SCVMPs (and lactobacilli) comprised in the compositions and if they do, the regimen should be adjusted (e.g., timing, dosing, sequencing, etc.) to minimize the interference. Dosage forms and formulations Multiple dosage forms comprising a SCVMP suitable for the vaginal delivery are contemplated herein, and include a suspension, spray, gel, cream, ointment, powder, (gelatin or vegetable cellulose) capsule, solution for lavages or douches, foams, films, ovules, a vaginal insert (e.g. tampon), tablets, disk, wafer (e.g., drying on film, by vaporization), or a microencapsulated product employing excipients and formulation techniques known to those skilled in the art. Particularly preferred dosage forms include formed gels, lyophilized gels, tablets, frozen formulations and films. A number of suitable excipients can be used to formulate the SCVMP, such as bulking agents, polymers, carbon sources, mucoadhesive agents, or pH modifiers and/or buffers. The carbon source excipients may act as a carbon source for the microbiota contained in the SCVMP. Such carbon courses comprise mannitol, maltodextran, and Guar gum. Some excipients may further serve as mucoadhesive agents or as viscosity agents. Bulking agents may comprise one or more of mannitol, micro-crystalline cellulose, maltodextran, guar gum, inulin, 58  \\4163‐8733‐4730  v3                or alginic acid (e.g., sodium alginate). Polymers may comprise structural polymers. In some embodiments, polymers comprise one or more of mucin, hyaluronic acid, polyvinyl alcohol, sodium CMC, polyvinylpyrrolidone, hydroxypropyl methylcellulose, carbopol (e.g., Carbopol 934), and poloxamer (e.g., poloxamer 407). Mucoadhesive agents comprise but are not limited to alginic acid (sodium alginate) and sodium CMC. Viscosity agents comprise but are not limited to Guar gum and Carbopol 934. Some excipients serve as pH modifiers and/or buffers, such as lactic acid and acetate buffer. Suitable formulations show little to no flow on suitable vertical surfaces and maintain high bacterial viability (e.g., CFU count) both upon formulation and during (long-term) storage. Desired formulation selection parameters include, for example, mucoadhesion (of reconstituted product, e.g., in the vaginal tract); viscosity (of reconstituted product), e.g., final viscosity for gel-based product needs to be syringeable at ambient temperature and preferably congealed at 37 ⁰C (at body temperature, e.g., in the vaginal tract); total sugar content (of reconstituted product), e.g., ideally at or lower than physiological concentration (about 0.5 – 1.0 mg/mL); volume of reconstituted product, e.g., up to 3 mL; hydration rate / disintegration rate (e.g., of gel/matrix), e.g., sufficient physical integrity to provide desired release rate; pH, e.g., between about pH 3.4- 3.9 (e.g., to promote inhibition of competitive vaginal bacteria); water activity / moisture content (e.g., of dried formulations), e.g., between 0.5 – 3% water (e.g., for longer term dried formulation stability); microbial diversity, e.g., relative abundance of Lactobacillus species, such as, e.g., L. crispatus, L. gasseri, L. jensenii, and L. iners; total dose / potency, e.g., preferably at least about 1x10 5 CFU/VCC, at least about 10 6 CFU/VCC, at least about 10 7 CFU/VCC or at least about 10 8 CFU/VCC per administration (per dose), shelf-life (not reconstituted) at various temperatures, and microbial limits, e.g., absence of microorganisms such as, Pseudomonas aeruginosa, Candida albicans, Staphylococcus aureus, Ph Eur criteria 5.1.4, 2.6.12 & 2.6.13). Suitable testing methods include standard assays, such as, plate count (e.g., MRS agar), e.g., for life bacteria count, dose determination, shelf-life; rheometer, e.g., for mucoadhesion and viscosity, pH meter, Karl Fisher / water activity meter, Ph Eur testing, e.g., for microbial loads. SCVMPs can be lyophilized and formulated into, e.g., gels and tablets as well as other dosage forms that can be filled with lyophilized products, such as, e.g., capsules. SCVMPs can also be formulated into gels that can be frozen, as well as into liquid media (e.g., with glycerol) 59  \\4163‐8733‐4730  v3                that can be frozen. SCVMPs can also be formulated into (air-dried) films, that could be, e.g., shaped like disks. Losses in viability range from approximately 0.5 log to 1 log at the formulation step depending on excipient and dosage form. In preferred embodiments, the SCVMP of the invention is provided in a dosage form selected from a tablet, pre-formed gel, lyophilized gel, liquid formulation, frozen formulation, film-forming formulation or film. A dose of the SCVMP compositions of the invention may comprise at least 1x10 2 , 1x10 3 , 1x10 4 , 1x10 5 , 1x10 6 , 1x10 7 , or 1x10 8 colony forming units (CFUs). In some embodiments, a dose of the SCVMP compositions comprises 1x10 2 to 1x10 12 CFUs. In some embodiments, a dose of the SCVMP compositions comprises 1x10 3 to 1x10 12 , 1x10 4 to 1x10 12 , 1x10 4 to 1x10 11 , 1x10 5 to 1x10 8 or 1x10 4 to 1x10 9 CFUs. In some embodiments of the methods described herein, the female subject is administered a single dose of SCVMP. In other embodiments of the methods described herein, the female subject is administered multiple doses of SCVMP. In some embodiments, multiple doses of the SCVMP are administered to the subject over multiple days. In some embodiments, multiple doses of the SCVMP are administered to the subject over consecutive days. In some embodiments, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 doses of the SCVMP are administered to the subject. In some embodiments, three doses of the SCVMP are administered to the subject. In some embodiments, three doses of the SCVMP are administered to the subject, wherein one dose is administered to the subject on each of three consecutive days. In some embodiments, two doses of the SCVMP are administered to the subject. In some embodiments, two doses of the SCVMP are administered to the subject, wherein one dose is administered to the subject on each of two consecutive days. In some embodiments, one dose of the SCVMP is administered to the subject. In some embodiments, doses of the SCVMP are administered repeatedly to the subject until the subject´s dysbiotic vaginal microbiota is Lactobacillus-dominant (e.g., comprises at least 90% relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri). In some embodiments, doses of the SCVMP are administered repeatedly to the subject until the subject´s dysbiotic vaginal microbiota comprises at least 60%, 70%, 80%, 90% or 95% Lactobacillus species, wherein the species are selected from Lactobacillus crispatus, Lactobacillus jensenii, and/or Lactobacillus gasseri. 60  \\4163‐8733‐4730  v3                Pre-formed and frozen gels The SCVMP of the invention can be comprised in a pre-formed gel. In some embodiments, the pre-formed gel is provided in a vial, e.g., for drawing up into a syringe. In some embodiments, the pre-formed gel is provided in a suitable applicator, e.g., as shown in Fig. 13. The pre-formed gel may be stored frozen or refrigerated depending to maintain the stability of the SCVMP. In some embodiments, the pre-formed gel comprises hyaluronic acid. In some embodiments, hyaluronic acid is comprised in a concentration of about 0.3 – 3%. In some embodiments, hyaluronic acid is comprised in a concentration of about 0.5 – 2%. In some embodiments, the pre-formed gel comprising hyaluronic acid may be frozen at -80°C. In some embodiments, the frozen pre-formed gel comprising hyaluronic acid is substantially stable for a time period of at least 3 months, 6 months, 9 months, 12 months, 18 months or longer. Lyophilized gels The SCVMP of the invention can be comprised in a lyophilized gel. The lyophilized gel may is stable and may be stored for extended periods of time at 2-8°C. The lyophilized gel comprises the lyophilized SCVMP and a gel forming excipient. The lyophilized gel may be supplied in a vial. The lyophilized gel can be reconstituted prior to administration (e.g., in a clinical or home setting) with a reconstitution agent. In some embodiments, the reconstitution agent comprises a gel, a gel forming agent, or a liquid. The liquid may comprise water, saline or another liquid suitable for reconstitution and subsequent administration to a subject. In particular embodiments, the lyophilized gel comprising the SCVMP of the invention further comprises sodium-carboxymethylcellulose (Na-CMC). In some embodiments, Na-CMC is comprised in a concentration of about 1 – 3%. In some embodiments, Na-CMC is comprised in a concentration of about 2%. In particular embodiments, the lyophilized gel comprises the SCVMP of the invention and hyaluronic acid. In some embodiments, hyaluronic acid is comprised in a concentration of about 0.3 – 3%. In some embodiments, hyaluronic acid is comprised in a concentration of about 0.5 – 2%. In particular embodiments, the lyophilized gel comprises the SCVMP of the invention and hyaluronic acid and sodium-carboxymethylcellulose (Na-CMC) at the above concentrations. The lyophilized gel comprising NA-CMP, hyaluronic acid, or a combination of both, is stable at 2-8°C or at -20°C for a time period of at least 3 61  \\4163‐8733‐4730  v3                months, 6 months, 9 months, 12 months, 18 months or longer. In some embodiments, the lyophilized gel comprising hyaluronic acid may be frozen at -80°C. In some embodiments, the frozen lyophilized gel comprising hyaluronic acid is stable for a time period of at least 3 months, 6 months, 9 months, 12 months, 18 months or longer. In some embodiments, the lyophilized gel and the reconstitution agent are provided as a kit. Film-forming formulations The SCVMP of the invention can be comprised in a film-forming formulation. The SCVMP of the invention can be formulated with polymeric excipients, wherein the polymeric excipients have bioadhesive properties and film-forming capacity. Exemplary polymeric excipients for film-forming formulations include polyvinyl alcohol (PVA), sodium lactate and lactic acid. In particular embodiments, the film-forming formulation comprises polyvinyl alcohol (PVA). In some embodiments, the PVA is comprised in a concentration of about 10 – 25%, 10- 20%, or about 12-15%. In particular embodiments, the film-forming formulation comprises PVA in a concentration of about 12%. In some embodiment, the film-forming formulation comprises PVA, e.g., in a concentration of about 10-25%, 10-20%, 12-15% or 12%, and is air-dried. In some embodiments, the film-forming formulation is provided as a disc or wafer. In some embodiments, the film-forming formulation is provided as a mucoadhesive pessary or patch. The film-forming formulation is substantially stable for a time period of at least 3 months, 6 months, 9 months, 12 months, 18 months or longer at 2-8°C. In some embodiments, the film-forming formulation rapidly disperses or dissolves in contact with fluids, e.g., cervicovaginal solution, to intravaginally form a viscous and bioadhesive gel. In some embodiments, formation of a bioadhesive dispersion is retained in the vagina for prolonged periods of time. Tablets The SCVMP of the invention can be comprised in a tablet. The tablet may comprise agents with gel-forming properties, muco-adhesive properties, or a combination of both. The tablet may further comprise excipient, such as swelling agents, bulking agents, lactic acid, carbopol, HPMC, alginate, or sodium-carboxymethylcellulose (Na-CMC). In some embodiments, the bulking agent comprises microcrystalline cellulose, HPMC / PVP, maltodextran, or poloxamer 407. In particular embodiments, the tablet comprises the SCVMP of 62  \\4163‐8733‐4730  v3                the invention and Na-CMC. In particular embodiments, the tablet comprises the SCVMP of the invention and polyvinylpyrrolidone (PVP). The tablet may further be substantially stable, e.g., substantially retain Lactobacilli viability. The tablet may be substantially stable at 2-8°C or at room temperature (about 25°C) for a time period of at least 3 months, 6 months, 9 months, 12 months, 18 months or longer. In particular embodiments, the tablet comprises the SCVMP of the invention and sodium-carboxymethylcellulose (Na-CMC) and is stable at 2-8°C or at room temperature (about 25°C) for a time period of at least 3 months, 6 months, 9 months, 12 months, 18 months or longer. In particular embodiments, the tablet comprises the SCVMP of the invention and polyvinylpyrrolidone (PVP) and is stable at 2-8°C or at room temperature (about 25°C) for a time period of at least 3 months, 6 months, 9 months, 12 months, 18 months or longer. Liquid formulations The SCVMP of the invention can be comprised in a liquid formulation. In some embodiments, the liquid formulation may be provided as a frozen formulation. In some embodiments, the liquid formulation is provided with gelling agents in a kit. The liquid formulation may comprise a cryoprotectant, such as glycerol, wherein the glycerol concentration is optionally less than 25%, less than 20%, less than 15%, or less than 10%. In some embodiments, the liquid formulation may be frozen, e.g., at -20°C or -80°C, and substantially retains Lactobacillus viability. In some embodiments, the liquid formulation further comprises lactic acid. In some embodiments, the liquid formulation comprises lactic acid in a concentration of about 0.5 to 2%, preferably in a concentration of about 1-1.5%. In a preferred embodiment, the liquid formulation comprises lactic acid and a cryoprotectant, such as glycerol. In some embodiments, the frozen liquid formulation comprising the cryoprotectant, and optionally lactic acid, is substantially stable for a time period of at least 3 months, 6 months, 9 months, 12 months, 18 months or longer. In some embodiments, the liquid formulation comprising the SCVMP is provided with a gelling agent as a kit. In some embodiments, a frozen liquid formulation comprising the SCVMP is provided with a gelling agent as a kit. In some embodiments, a frozen liquid formulation which does not comprise the SCVMP is provided with a lyophilized gel as a kit, wherein the lyophilized gel comprises the SCVMP. 63  \\4163‐8733‐4730  v3                In some embodiments, the liquid formulation (or composition) comprising the SCVMP further comprises saline or phosphate-buffered saline (PBS). In some embodiments, the liquid formulation comprises a ratio of SCVMP relative to saline or PBS that is in a range of 1:10 to 10:1. In some embodiments, the ratio of SCVMP relative to saline or PBS is about 10:1, about 9:1, about 8:1, about 7:1, about 6:1, about 5:1, about 4:1, about 3:1, about 2:1, about 1:1, about 1:2, about 1:3, about 1:4, about 1:5, about 1:6, about 1:7, about 1:8, about 1:9, or about 1:10. In some embodiments, a liquid formulation is frozen and stored at cold temperatures (e.g., below 0 degrees Celsius, below -20 degrees Celsius, or at about -80 degrees Celsius) for a period of time prior to administration to a subject. In some embodiments, the liquid formulation undergoes one or more freeze-thaw cycles. In some embodiments, the liquid formulation is frozen and then subsequently thawed prior to administration via an insemination catheter to a subject. In some embodiments, the liquid formulation is frozen and stored in a prefilled syringe. Methods of Producing Preparations and Compositions and Donor considerations Aspects of the invention include methods of producing a SCVMP as described herein. These methods include selecting a suitable female donor to provide samples of vaginal fluids, preferably a cervicovaginal secretion, and processing the samples to provide compositions (such as pharmaceutical compositions) comprising the SCVMP described herein. In one aspect, the method of producing a SCVMP, as described herein comprises: a. Processing a microbiota sample from a donor female genitourinary tract, e.g., a vaginal mucosal sample or cervicovaginal secretion, comprising urogenital microbes and vaginal mucosal fluid from the vaginal cavity of a healthy donor subject in a centralized processing facility, b. Assessing the absence of one or more pathogens, c. Assessing viability and/or quantity of the urogenital microbes, and d. Releasing the composition comprising the processed vaginal mucosal sample from quarantine for use in infertility treatment (e.g., IVF procedure), if a predetermined level is obtained in step (b) and (c). In some embodiments, the method may further comprise one, two, three, four or all of the following steps: a. Adding at least one pharmaceutically acceptable diluent, excipient or carrier; 64  \\4163‐8733‐4730  v3                b. Adjusting the pH, osmolarity and/or viscosity of the vaginal mucosal fluid; c. Adding one or more cryoprotectants (e.g., for freezing) and/or one or more lyoprotectants (e.g., for drying); d. Formulating the processed mucosal fluid into a dosage form comprising a powder, a solid, a semi-solid, or a liquid: e. Partitioning the vaginal mucosal fluid into discrete units, each unit comprising an effective dose of urogenital microbes, wherein the effective dose of urogenital microbes comprises at least 10 5 colony forming units (CFU), preferably at least 10 6 colony forming units (CFU), more preferably at least 10 7 colony forming units (CFU); f. Storing the refrigerated, frozen or dried vaginal mucosal fluid sample or processed preparation under quarantine; g. Holding the refrigerated, frozen or dried vaginal mucosal fluid sample or processed preparation under quarantine until any completion of any combination of (a) testing the donor to exclude the substantial presence of one or more transmissible pathogens, (b) confirming the composition and viability of the urogenital microbes comprised, or (c) further confirming the health of the donor by a plurality of post-screening tests; h. Standardizing the cell count and/or the quantity or concentration of the urogenital microbes comprised in the preparation, optionally by adding an inert filler; and i. Releasing the refrigerated, frozen or dried mucosal fluid sample or processed preparation from quarantine to define the substantially complete vaginal microbial preparation. In some embodiments for the methods provided herein, one or more (pharmaceutically acceptable) excipients or carriers are added to the mucosal fluid or the mucosal fluid is otherwise further processed. In some embodiments, one or more of: pH, osmolarity and/or viscosity are adjusted, e.g., by adding acids, bases, buffers, and/or salts to the mucosal fluid. In some embodiments, the composition is frozen or dried (e.g., spray dried/lyophilized) prior to administration to the recipient subject. In some embodiments, the composition is not administered to the recipient subject as freshly harvested mucosal fluid, but is frozen or dried (e.g., lyophilized) prior to administration to the recipient subject. In some embodiments, the 65  \\4163‐8733‐4730  v3                composition is stored in quarantine until the donor samples comprising the substantially complete vaginal microbial composition and/or the donor subject have been assessed for the presence of pathogens, and/or transmittable diseases. The donor female is generally healthy, does not exhibit dysbiosis of the vaginal microbiota and optionally is subjected to one or more additional health tests. The SCVMP provided herein (i) comprises one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9 % of all detectable bacterial species of the preparation; and (ii) comprises less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. For example, the methods of producing a SCVMP includes a step of providing a microbiota sample (such as a cervicovaginal secretion) from a healthy female donor and a step of releasing from quarantine (e.g., based on meeting one or more predetermined (quality) parameters, such as, e.g., those obtained from performing one or more of steps 5(a) to 5(e) below) a processed sample as a (pharmaceutical) composition, e.g., for administration to a female recipient in need of a SCVMP. Generally, the step of providing and processing of a microbiota sample (such as vaginal mucosal sample or a cervicovaginal secretion) from a healthy female donor can include one, two, three, four, five or more steps, and any combinations, e.g., any two, three, four, five or more steps, including: (1) adding a diluent (e.g., saline), buffer, or other excipient to the microbiota sample to create a diluted sample; (2) removing a portion of the diluted microbiota sample for testing (e.g., nucleic acid sequencing); (3) pre-cooling for either refrigeration or freezing of the remainder of the microbiota sample; (4) storing the refrigerated or frozen microbiota sample under quarantine, and/or (5) holding the refrigerated or frozen microbiota sample under quarantine until completion of any combination of (a), (b), (c), (d), and/or (e): (a) testing the donor to exclude the presence of transmissible pathogens (e.g., blood, vaginal swab, and/or urine sample testing), (b) confirming the composition and viability of the donor sample microbiota (e.g., lactobacilli), (c) further confirming the health of the female donor by a plurality of post- screening tests occurring within a time period of 30-90 days post-donation (or alternatively: 10- 120 days, or 30-60 days), (d) testing for presence of sperm cells, and/or (e) testing pH of the sample (e.g., Figure.14). Any of steps (1) to (5) and 5(a) to 5(e) are optional and can be carried out sequentially or in parallel in any particular order that is desired. 66  \\4163‐8733‐4730  v3                In one embodiment, the method of producing a SCVMP comprises: A. providing a microbiota sample from a donor female genitourinary tract; wherein step A comprises one, two, or three of steps (1), (2), (3) or any combination thereof, and both steps (4) and (5): (1) adding a diluent to the microbiota sample to create a diluted sample, (2) removing a portion of the diluted microbiota sample for testing (e.g., nucleic acid sequencing), (3) pre-cooling for either refrigeration or freezing of the remainder of the microbiota sample, (4) storing the refrigerated or frozen microbiota sample under quarantine, (5) holding the refrigerated or frozen microbiota sample under quarantine until any completion of any combination of (a) testing the donor to exclude the substantial presence of one or more transmissible pathogens (e.g., blood, and/or cervicovaginal secretions, and/or urine sample testing), (b) confirming the composition and viability of the microbiota, or (c) further confirming the health of the female donor by a plurality of post-screening tests occurring within a time period of 30-90 days post-donation; and B. releasing the refrigerated or frozen microbiota sample from quarantine to define the SCVMP. Step (1) may include, e.g., adding an acidifying agent (e.g., to adjust the pH of the sample); adjusting the viscosity of the sample (e.g., to aid administration as described herein); adjusting the isotonicity/osmolarity; and/or adding one or more other active agents, such as described herein, including spermicides, antimicrobial agents, hormonal agents, anti- inflammatory agents, and optionally prebiotics. In one embodiment, the acidifying agent is lactic acid. For step (2), the microbiota sample (e.g., a sample of vaginal fluid/vaginal secretion) is preferably at least 75 mg or 100 mg, more preferably at least 150 mg and a portion is removed for nucleic acid sequencing. The microbiota sample may be 75 mg, 100 mg, 150 mg, 200 mg, 250 mg, or 300 mg. In a further embodiment, the microbiota sample (e.g., a sample of vaginal fluid/vaginal secretion) is at least 200 mg, 300 mg, 400 mg, 500 mg, 500 mg, 700 mg or more. In one embodiment, the microbiota sample (e.g., a sample of vaginal fluid/vaginal secretion) is at least 500 mg. 67  \\4163‐8733‐4730  v3                Sequencing is performed to assess the microbial community of the donor microbiota sample and to select suitable donor females. Preferably, the presence of one, two, three, four or five different bacterial species from the genus Lactobacillus is detected in the donor microbiota sample by nucleic acid sequencing. Most preferably, one (dominant) bacterial species from the genus Lactobacillus is detected in the donor microbiota sample by nucleic acid sequencing. In some embodiments, nucleic acid sequencing determines that the donor microbiota sample comprises 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, about 99.5%, about 99.9%, 80-99.9%, 75%-95%, 85%-95%, 85%-99.9%, or 90%-99.9% lactobacilli of one species of the total of all detectable species in the preparation. In some embodiments, nucleic acid sequencing determines that the donor microbiota sample comprises 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99.9%, about 99.5%, about 99.9%, 80-99%, 75%-95%, 85%-95%, 85%-99.9%, or 90%-99.9% lactobacilli of more than one species (e.g., two, three, four, or five species) of the total of all detectable species in the preparation. Preferably, nucleic acid sequencing determines that the donor microbiota sample comprises species of Lactobacillus selected from: a) Lactobacillus crispatus; (b) Lactobacillus iners; (c) Lactobacillus jensenii; (d) Lactobacillus gasseri, or any combination thereof (including combinations of two, three, or all four species). Optionally, nucleic acid sequencing is performed to identify any pathogens or pathobionts in the donor sample, e.g., to determine that a donor sample is substantially free of pathogens and pathobionts. For example, nucleic acid sequencing is preformed to detect the presence of one or more of Gardnerella spp., Atopobium spp., and/or Prevotella spp. In some embodiments, nucleic acid sequencing is preformed to detect the presence of one or more of Gardnerella spp., Atopobium spp., Prevotella spp, and/or Fannyhessa vaginae. In some embodiments, nucleic acid sequencing is performed to detect the presence of one or more of Gardnerella vaginalis, Bacteroides, Mobiluncus spp., Sneathia spp., and Mycoplasma hominis. In some embodiments, nucleic acid sequencing is preformed to detect the presence of one or more of Escherichia, Enterococcus, Pseudomonas, Proteus, Klebsiella, Streptococcus, Staphylococcus, Gardnerella, Ureaplasma, Bacteroides, Peptococcus, Neisseria, Serratia, Corynebacterium, Clostridium, and Candida. The presence of any one or more of these species suggests the displacement of healthy vaginal lactic acid producing bacteria by unwanted species, 68  \\4163‐8733‐4730  v3                signaling the presence of vaginal dysbiosis. Donor samples containing more than about 1%, 3%, 5%, 8%, 10% or more than about 15% of species belonging to one or more unwanted species are not used for further processing to generate the SCVMPs described herein. In one embodiment, donor samples containing more than about 5% of species belonging to one or more unwanted species (e.g., are Gardnerella spp., Atopobium spp., and/or Prevotella spp.) are not used for further processing to generate the SCVMPs described herein. Optionally, nucleic acid sequencing is performed to identify the presence of any antimicrobial resistance (AMR) genes in the donor sample, e.g., to determine that a donor sample is substantially free of antimicrobial resistance (AMR) genes. Antimicrobial resistance (AMR) genes include genes that confer resistance to one or more antibiotics, including, e.g., aminoglycosides, beta-lactams, tetracyclines, and sulfonamides (e.g., as described and cataloged in the NCBI National Database of Antibiotic Resistant Organisms (NDARO)). It will be appreciated that due to extensive use of antibiotics the cut-off is not zero. Some reasonable allowance for the presence of AMR genes is made. The precise cut-off can be determined by one of ordinary skill, based on, e.g., the nature of the AMR genes (e.g., degree of health concern) and public health recommendations. Alternatively, or in addition, tests are performed to determine that a donor sample is substantially free of one or more gram-negative toxins (e.g., endotoxin or lipopolysaccharide (LPS) and other secreted exotoxins and enterotoxins), pathogenicity factors/ bacterial virulence factors, and/or colonization factors (e.g., motility, adherence, invasiveness, etc.). Optionally, tests are performed (e.g., by microscopy) to identify the presence of any human sperm (spermatozoa) in the donor sample, e.g., to determine that a donor sample is substantially free of human sperm (spermatozoa). Step (3) may include pre-cooling for either subsequent refrigeration (e.g., at 4° C) or freezing (e.g., −18° C or −80° C), depending on the desired time period for storage, quarantine and use for administration. This step may also include freeze-drying (lyophilizing), e.g., for easy storage, packaging, formulation and transport. Further, this step may optionally include viability testing, e.g., upon refrigeration, freezing, or freeze-drying, e.g., viability of the lactobacilli comprised in the SCVMPs. Steps (4) and (5) include storing the refrigerated, frozen or freeze-dried microbiota sample under quarantine, and holding the stored microbiota sample under quarantine until 69  \\4163‐8733‐4730  v3                completion of a number of tests conducted on the donor microbiota sample and/or the sample donor. The quarantine is lifted, and the sample released for use as a SCVMP or composition (e.g., pharmaceutical composition), e.g., for administration to a recipient female, upon the sample and/or the donor passing one or more predetermined tests (sample quality and/or female donor health tests). Those include one or more of: (a) testing the donor to exclude the presence of transmissible pathogens (e.g., blood, vaginal swab, and/or urine sample testing); (b) confirming the composition and viability of the donor sample microbiota (e.g., lactobacilli), and/or (c) further confirming the health of the female donor by a plurality of post-screening tests occurring within a time period of 30-90 days post-donation (or alternatively: 10-120 days, or 30-60 days). Step (5) testing to exclude the presence of transmissible (and potentially infectious) pathogens (e.g., blood, vaginal swab, and/or urine sample testing) may include determining that the female donor is substantially free of any one or more (two or more, three or more, or four or more) of: (i) bacteria involved in bacterial vaginosis (e.g., Gardnerella and Mobiluncus), (ii) yeast (e.g., Candida, Cryptococcus, and Saccharomyces species), (iii) sexually transmitted pathogens (including Neisseria gonorrhea, Chlamydia trachomatis, and Trichomonas vaginalis), (iv) bacteria involved in urinary tract infections (e.g., E. coli, Staphylococcus, Chlamydia, and Mycoplasma), and (v) viruses (e.g., HIV, human papilloma virus (HPV), hepatitis B virus, hepatitis C virus, HSV-2). Step (5) testing may include determining that the female donor is substantially free of any one or more sexually transmitted infections or diseases (STI, STD), including chlamydia, chancroid, crabs (pubic lice), genital herpes, genital warts, Hepatitis B, human immunodeficiency virus/acquired immunodeficiency syndrome, human papilloma virus, trichomoniasis, molluscum contagiosum, pelvic inflammatory disease, syphilis, gonorrhea, and yeast infections. Step 5 testing may include determining that the female donor does not exhibit a dysbiosis in the vaginal tract, e.g., by one or more established tests for bacterial vaginosis (BV) and bacterial infections. Such tests include Amsel Criteria, Nugent Gram-stain scoring system, and Hay-Ison Criteria. Alternatively, other methods may be used to determine the absence of dysbiosis, e.g., using the BV Blue test or Affirm Microbial Identification Test. Amsel Criteria include the presence of three of the following four symptoms: (a) thin homogeneous malodorous discharge; (b) vaginal pH fluid >4.5; (c) an amine odor from vaginal 70  \\4163‐8733‐4730  v3                fluid when 10% KOH is added; and (d) the presence of “clue” cells (vaginal epithelial cells with adherent bacteria that obscure cell margins) (Amsel et al., Am. J. Med.74:14-22 (1983)). The Nugent Gram-stain scoring system involves assessment of a normally prepared Gram stain for relative abundance of three morphotypes of bacteria, and then calculating the so-called Nugent score based on the amounts of large Gram-positive rods (lactobacilli morphotype; decrease in lactobacilli is scored as 0 to 4), small Gram-negative and variable rods (Bacteroides and Gardnerella morphotype; scored as 0 to 4), and curved gram-variable rods (Mobiluncus spp. morphotype; scored as 0 to 2). The Nugent score can range from 0 to 10, with scores of 0-3 deemed normal (non-BV), 4-6 intermediate, and 7-10 positive for BV. Hay-Ison Criteria (alternatively Ison‐Hay scoring system) suggests five grades of flora: a) Grade 0, epithelial cells with no bacteria; b) Grade I, normal vaginal flora (lactobacillus morphotypes alone); c) Grade II, reduced numbers of lactobacillus morphotypes with a mixed bacterial flora; d) Grade III, mixed bacterial flora only, few or absent lactobacillus morphotypes; e) Grade IV, Gram positive cocci only. Grades 0, I, and IV are found in women without BV. Grade II is intermediate and not found in women with BV as defined by Amsel criteria. Grade III is consistent with BV as diagnosed by Amsel criteria. Grade III flora are indicative of BV (C.A. Ison and P.E. Hay, Sex Transm. Infect.2002 Dec;78(6):413-5). The BV BLUE test (Gryphus diagnostics) detects sialidase activity, an enzyme produced by BV-associated bacteria such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp. A vaginal fluid sample is placed in the test vessel which contains a chromogenic substrate for sialidase. After incubation, a developer solution is added, and if the sample contained a high level of sialidase, a blue or green color is seen. Samples containing no sialidase, or low levels of this enzyme, will generate a yellow color in the reaction. The AFFIRM Microbial Identification Test (Beckton Dickinson) is a DNA probe-based diagnostic test for the differential detection and identification of the three types of vaginitis- associated organisms: Candida spp., G. vaginalis and T. vaginalis. In some embodiments, donor females are selected from generally healthy, pre- menopausal women, of ages 18 years and older with regular, predictable menstrual cycles. In some embodiments, donor females are selected from generally healthy, post-menopausal women. In some embodiments, donor females are selected from both pre- and post-menopausal women. 71  \\4163‐8733‐4730  v3                Donors can take oral contraceptives, hormonal contraceptives, hormonal intrauterine devices or no contraceptives. Donors are substantially free of vaginal symptoms, such as odor, discharge, or itching. Optionally, donors do not use or perform one or more of (or all of a-e) during the sample donation period, e.g., from initial donor screening to the final donation: a) use vaginal feminine products that are inserted, e.g. tampons, menstrual cups, sex toys, though sanitary napkins are acceptable; b) use other vaginal products, such as, e.g., cleansing products, spermicides, lubricants, hygiene powders and sprays); c) have vaginal and anal intercourse; d) take baths, go swimming, sit in a hot tub, and/or e) wear thong underwear. Donors may be excluded if they exhibit one or more of the following (e.g., test above a set of predetermined thresholds, e.g., concerning viral, fungal, and bacterial pathogen and/or pathobiont load, for which individual maximal thresholds may be set, e.g., above zero, such as, e.g., being substantially free thereof): (a) a health history of one or more of: bacterial vaginosis, recurrent yeast infection, trichomoniasis, syphilis, human papilloma virus (HPV) including genital warts, high grade pap smear, herpes, pelvic inflammatory disease, recurrent urinary tract infection, and mycoplasma, or any combination thereof; (b) testing positive for one or more of: HIV, Hepatitis A/B/C, syphilis, Human T-lymphotrophic Virus (HTLV)-I/II, WNV, Epstein- Barr Virus (EBV), rubella, toxoplasma gondii, Herpes Simplex Virus (HSV)-1/2, , chlamydia, gonorrhea, mycoplasma genitalium, trichomonas vaginalis, HPV, and other yeast or bacteria that are considered pathogenic/abnormal and/or show antibiotic resistance, or any combination thereof, (c) vaginal fluid/cervicovaginal secretions not dominated by one of the common vaginal lactobacillus species, e.g., as determined by qPCR; and/or (d) history of gonorrhea or chlamydia (e.g., within 12 months prior to screening), or any combination of (a), (b), (c) and (d). Further, donors may be excluded if they exhibit one or more of the following: hysterectomy, intra-uterine device insertion or removal, cervical cryotherapy, or cervical laser treatment (e.g., within 2 months prior to screening), any condition requiring regular periodic use of systemic antibiotics, use of long-acting hormonal treatments, social, medical, or psychiatric condition, including history of drug or alcohol abuse, menopause (e.g., defined as more than 12 consecutive months of amenorrhea without another known cause), irregular menstrual cycles, use of other medication, or any combination thereof. Preferably, donors are not currently pregnant or breastfeeding. 72  \\4163‐8733‐4730  v3                If desired, donors exhibiting one or more of cytomegalovirus (CMV), Rubella, and Varicella Zoster Virus (VZV) IgG, or any combination thereof, will only be matched with CMV positive and/or Rubella and/or VZV positive recipients, or can be excluded. Methods of Administration Aspects of the invention include methods for vaginal administration to a human female subject (e.g., an infertile female subject undergoing or planning to undergo an assisted reproductive procedure) of a composition comprising a SCVMP described herein (e.g., to treat infertility). The methods may include using a device for administration, e.g., these methods would normally be carried out by a healthcare provider (e.g., in a clinic). For example, the composition comprising a SCVMP is provided frozen, e.g., in a cryo-vial, then thawed and pre- heated to 37°C and then dispensed into a syringe/applicator by a healthcare provider and then administered to a recipient. Alternatively, the methods include using an alternative dosage form described herein, such as, e.g., a suppository, tablet, capsule, film, cream, etc. The methods can, if desired, be carried out by the recipient herself, e.g., by self-administration (e.g., at home). The methods may also include other healthcare related activities, such as diagnosing a health issue and providing standard of care in addition to providing a SCVMP or composition described herein. The activities can include one or more combination therapies provided herein. For example, the methods for administration described herein may further comprise administering antimicrobial agents, antifungal agents, antibacterial agents, antiviral agents, antibiotics, antiparasitic agents (e.g., with activities against Trichomonas vaginalis), anti-inflammatory agents, and the like. Administration of the SCVMP may be performed by administering the SCVMP to the vaginal cavity or endometrium of the subject. In some embodiments, in which administration is carried out using a device, the device typically includes an open end (e.g., a tip) for insertion into the vaginal cavity, and a dispensing end (e.g., a plunger or piston) to expel the composition through the open end. The administration steps include: a) introducing the open end into a vaginal cavity, b) expelling the composition into the vaginal cavity, c) removing the device from the vaginal cavity (after administering the desired dose). Administration is preferably carried out with the recipient being in a lithotomy position, e.g., with the female recipient in a lithotomy position. In some embodiments, the 73  \\4163‐8733‐4730  v3                recipient is to remain in a lithotomy position for at least 5 minutes, at least 10 minutes, at least 20 minutes, at least 30 minutes before returning to an upright position to allow the SCVMP or composition sufficient residence time in the vaginal cavity, e.g., sufficient contact time with the mucosal or endometrial surfaces of the vagina. In some embodiments, the administration is carried out targeting areas high in the vaginal cavity, e.g., near the vaginal fornices. If desired, the menstrual cycle of the recipient female is taken into account when determining the timing of administration. For example, the procedure may be avoided during menstrual discharge. In some embodiments, a time other than during menstrual discharge is preferred for carrying out the administration, including, e.g., during a time window that includes prior to ovulation and prior to menstrual discharge. In some embodiments, the precise steps, timing, and length of the procedure varies between recipients (and is, e.g., determined by a healthcare provider) in order to provide optimal conditions for the bacteria (e.g., lactobacilli) comprised in the SCVMP to colonize and become established (engrafted) in the vagina of the recipient female. Methods of Treatment and Recipient considerations Suitable female recipients include females (e.g., infertile female subjects) exhibiting a dysbiosis of the vaginal microbiota and those that are in need of treatment for dysbiosis, such as dysbiosis associated with an infection (e.g., with a pathogen), and/or (chronic) inflammation. In some embodiments, suitable female recipients include female subjects (e.g., infertile female subjects) that are undergoing or planning to undergo an assisted reproductive procedure (e.g., IVF). Aspects of the invention relate to methods for restoring a healthy human vaginal microbiota balance in the female genitourinary tract. The methods include administering to a female subject in need of restoration of vaginal microbiota balance an effective amount of a composition comprising a SCVMP described herein for the purpose of providing a community of microbial species that are capable of colonizing or inhabiting the human vagina or vaginal epithelium and that provide a microbial niche that discourages the growth of pathogenic microbes and is not pro-inflammatory (e.g., is anti-inflammatory). The methods include administering to a female subject in need of vaginal microbiota balance an effective amount of a 74  \\4163‐8733‐4730  v3                composition comprising a SCVMP described herein for the purpose of maintaining healthy vaginal microbiota or a healthy vaginal microbiota balance. In one aspect, the invention provides a composition for use in treating infertility, dysbiosis, and/or inflammation in the female genitourinary tract of a human subject (e.g., an infertile subject undergoing or planning to undergo an assisted reproductive procedure (e.g., IVF), wherein the female subject exhibits a dysbiotic microbiota in the genitourinary tract, said method comprising administering to the subject an effective amount of the composition, wherein the composition comprises a SCVMP, wherein the preparation (i) comprises one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise > 80-99.9% of all detectable bacterial species of the preparation; and (ii) comprises <5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; optionally wherein the composition comprises a pharmaceutically acceptable carrier or diluent. Inflammation and disorders, conditions or diseases associated with inflammation are used interchangeably and comprise acute and chronic inflammation. Dysbiotic vaginal microbiota may be associated with inflammation and/or infertility. The subject may be an asymptomatic subject, wherein an asymptomatic subject is characterized by having no Amsel´s criteria, Nugent score or other measures of symptoms associated with bacterial vaginitis (BV). In one aspect, the recipient is a asymptomatic dysbiotic woman. In some embodiments, a female subject is being concurrently administered (or has been previously administered) one or more fertility drugs. In some embodiments, a female subject suffering from infertility is being co-treated with one or more fertility drugs. In some embodiments, a fertility drug is intended to promote an artificial insemination (e.g., IUI) or an assisted reproductive procedure (e.g., IVF). A fertility drug may be selected from the group consisting of Clomiphene citrate (Clomid), Human chorionic gonadotropin (hCG), Follicle- stimulating hormone (FSH), Human menopausal gonadotropin (hMG), Gonadotropin-releasing hormone (GnRH), Gonadotropin-releasing hormone agonist (GnRH agonist), Gonadotropin- releasing hormone antagonist (GnRH antagonist), Antagon (ganirelix acetate), Dostinex(cabergoline) and Parlodel. 75  \\4163‐8733‐4730  v3                Vaginal wash In order to reduce the quantity of the pathogens in the vaginal cavity of the dysbiotic recipient, in some embodiments, prior to administering the pharmaceutical composition the vaginal cavity is rinsed, e.g., a vaginal wash is performed. The vaginal wash may be performed with an absorbent material pre-soaked in the wash solution. In one embodiment, the absorbent material is gauze. In some embodiments, a tampon- shaped gauze may be used. The wash is typically performed by a medical professional, such as a gynecologist, wherein the recipient is in the lithotomy position and the pre-soaked absorbent material is used with pliers to wash the surface of the vaginal epithelium. After performing the vaginal wash, excess wash solution may be absorbed by a dry absorbent material, e.g., a dry tampon-shaped gauze. The vaginal wash can be performed with any solution that is suitable for reducing the quantity of pathogens in the vaginal cavity, including but not limited to saline, antiseptic, or lactic acid. In some embodiments, the vaginal wash comprises a saline vaginal wash, lactic acid wash, or wash with an antiseptic solution. Suitable antiseptic solutions include chlorohexidine and povidone-iodine. In a particular embodiment, the vaginal wash is performed with saline. In another particular embodiment, the vaginal wash is performed with lactic acid, optionally wherein the lactic acid has a pH of about 3.5 – 4.5. In a particular embodiment, the vaginal wash is performed with lactic acid having a pH of about 3.8-4.3 or 3.8 to about 4.0. In a further particular embodiment, the vaginal wash is performed with an antiseptic solution, optionally wherein the antiseptic solution is chlorohexidine or povidone-iodine. In a particular embodiment, the vaginal wash is performed with povidone-iodine, wherein the solution comprises about 10% povidone-iodine. In a particular embodiment, the vaginal wash is performed with chlorhexidine, wherein the solution comprises about 0.5% chlorhexidine. In some embodiments, the vaginal wash is performed with chlorhexidine gluconate in the range 0.05%-0.4%. In some embodiments, a method of the disclosure will be as follows: (i) antiseptic wash; (ii) saline or PBS wash (e.g., to remove antiseptic); (iii) administration of one or more doses of the SCVMP on 1-3 consecutive days (e.g., up to three total doses per day, i.e., 1, 2 or 3 administrations on 1-3 consecutive days, optionally wherein each dose is preceded by an antiseptic wash); (iv) a waiting period of 1-12 weeks; and (v) implantation of an embryo implant (e.g., a fresh embryo that has never been cryopreserved; or a thawed embryo that has been 76  \\4163‐8733‐4730  v3                cryopreserved). In some embodiments that involve implantation of a fresh embryo, the embryo transfer is performed usually either three or five days after the retrieval of the egg. In some embodiments that involve implantation of a cryopreserved embryo, the embryo has been previously created, sometimes even years earlier, and then will be placed into the uterus after being thawed. In some embodiments, a method of the disclosure will be as follows: (i) (mild) antiseptic wash (e.g., chlorhexidine); (ii) saline wash (e.g., to remove the antiseptic); (iii) administration of one dose of the SCVMP each on 2 consecutive days, wherein only the first dose is preceded by an antiseptic wash, not the second; (iv) a waiting period of about 6-10 weeks (e.g., corresponding to two menstrual cycles), preferably about 8 weeks; and (v) implantation of an embryo (e.g., an embryo that has been cryopreserved), followed by standard-of-care for the assisted reproductive procedure that is being performed. In some embodiments that involve implantation of a cryopreserved embryo, the embryo has been previously created, sometimes even years earlier, and then will be placed into the uterus after being thawed. In some embodiments, following administration of the SCVMP, the female subject(s) is determined to have a detectable level of beta hCG hormone (e.g., detected using a pregnancy test). In some embodiments, following administration of the SCVMP, the female subject(s) is determined to have a clinical pregnancy. In some embodiments, following administration of the SCVMP, the female subject(s) maintains an ongoing pregnancy (e.g., to live birth). In some embodiments, following administration of the SCVMP, the female subject(s) does not have a pregnancy loss (e.g., miscarriage). Homeostasis of vaginal microbiota A healthy human vaginal microbiota balance includes establishment (including, e.g., engraftment) of a select variety of microbial species (including one or more Lactobacillus species) in which the relative numbers of each species or the sum of vaginal Lactobacilli (e.g. Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri) are in homeostasis, as measured post administration of a composition comprising the SCVMPs described herein. Homeostasis, generally, is a state in which the 77  \\4163‐8733‐4730  v3                relative abundance of each species in a population does not substantially vary over a given period of time, e.g., at least for 1 day, 3 days, 5 days, 7 days, 10 days, 14 days, 21 days, 30 days, 60 days, 90 days, 6 months, or at least 12 months, or, e.g., over several (1, 2, 3, 4, 5, 6) menstrual cycles in a reproductive age woman. Homeostasis may be measured, e.g., by metagenomic sequencing, such as MLST and MLVA, 16S sequencing and/or qPCR. If desired, CFU counts may be taken, e.g., to measure persistence of colony forming units of healthy bacteria). A healthy human vaginal microbiota balance at a homeostatic state (preferably rich in lactobacilli, e.g., at least 50%, 60%, 70% or at least 80% of lactobacilli, e.g., selected from one or more of: L. crispatus, L. iners, L. gasseri and L. jensenii) confers, e.g., resistance to perturbations caused by vaginal pathogens (non-pathogenic) and/or provide an anti-inflammatory environment and is stable for a period of time. However, a healthy vaginal microbiota does not require complete absence of all pathogens. Many healthy women have low levels of yeast and/or pathobionts present in their microbiota. In some embodiments, the methods for restoring a healthy human vaginal microbiota balance in the female genitourinary tract include providing a non-proinflammatory or anti- inflammatory environment in the genitourinary tract. In some embodiments, the compositions comprising a SCVMP described herein when administered (e.g., for treatment) provide anti- inflammatory activity to the genitourinary tract. In some embodiments, the compositions comprising a SCVMP described herein when administered (e.g., for treatment) do not provoke a local or systemic inflammatory or immune response in the subject or recipient. In some embodiments, the compositions comprising a SCVMP described herein when administered (e.g., for treatment) promote a local or systemic anti-inflammatory or immune response in the subject or recipient. In some embodiments, the compositions comprising a SCVMP described herein when administered (e.g., for treatment) provide maintenance of the balance of anti-inflammatory and proinflammatory mediators in vaginal epithelial cells of the genitourinary tract. Inflammatory markers Proinflammatory cytokines that can be modulated by the methods described herein include, e.g., IL-1β, IFN-ɣ, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17, IL-23, and TNF-α. In one embodiment, the administration of the SCVMP effects reducing or stabilizing the levels of inflammatory markers, wherein the markers comprise one or more of IL-1a, IFN-ɣ, IL- 78  \\4163‐8733‐4730  v3                18, IL-12, and MMP-10. In some embodiments, anti-inflammatory markers are increased after administration of the preparation of the invention. Anti-inflammatory and proinflammatory mediators upon administration and engraftment of the lactobacilli comprised in the SCVMPs described herein can be measured (e.g., collecting a vaginal sample (e.g., vaginal fluid/secretion) or a systemic sample, (e.g., blood) using suitable commercially available biomarker panels. Provided herein are methods of treating (chronic) inflammation of the female genitourinary tract. The methods include administering to a female subject in need of treatment an effective amount of a composition comprising a SCVMP described herein. Subjects treated by the methods described here include females exhibiting an inflammation (in some instances chronic inflammation) that may result in a number of adverse health outcomes, such as urinary tract infections (UTIs). In some embodiments, a subject exhibiting vaginal dysbiosis has elevated levels of pro- inflammatory or inflammasome-associated cytokines, proteins, metabolites, receptor or signaling molecules in the vagina, endometrium, and/or in the reproductive tract, relative to a control (e.g., a person who is not exhibiting vaginal dysbiosis). In some embodiments, the subject has elevated systemic levels of pro-inflammatory or inflammasome-associated cytokines, proteins, metabolites, receptor or signaling molecules (e.g., as measured in blood, e.g., venous blood). In some embodiments, the subject has elevated levels of pro-inflammatory or inflammasome- associated cytokines, proteins, metabolites, receptor or signaling molecules in menstrual blood (e.g., to detect local inflammation). Pro-inflammatory or inflammasome-associated cytokines that may be elevated in a female subject exhibiting vaginal dysbiosis include IL-1α, IL-1β, IL-2, IL-5, IL-6, IL-8, IL-12, IL-15, IL-17, IL-18, IP-10, MCP-1, TNFα, HIF-1α, COX-2 and VEGF. In some embodiments, at least one of IL-1, IL-1α, IL-1β, IL-6, or IL-18 is elevated in a female subject exhibiting vaginal dysbiosis. In some embodiments, IL-1α, IL-1β, IL-2, IL-5, IL-8, IL-15, IL-17, IP-10, COX-2, VEGF, IL-1α, IL-1β, and/or IL-18 are elevated in a female subject exhibiting vaginal dysbiosis. In some embodiments, Th1 cytokine levels (e.g., levels of IFNγ, IL-12, STAMBP or TNF) are elevated in the vagina, endometrium, and/or in the reproductive tract of a female subject exhibiting vaginal dysbiosis, relative to a control. 79  \\4163‐8733‐4730  v3                In some embodiments, levels of IGF-1, IL-4, IL-10, TGFβ and/or CCL5 are reduced in the vagina, endometrium, and/or in the reproductive tract of a female subject exhibiting vaginal dysbiosis, relative to a control. Administration of a SCVMP as described herein to a female subject (e.g., a female subject exhibiting vaginal dysbiosis) can, in some embodiments, cause a shift in the inflammatory biomarkers of the subject (e.g., inflammatory biomarkers in the vagina, endometrium, and/or in the reproductive tract). In some embodiments, administration of a SCVMP cause elevated levels of pro-inflammatory or inflammasome-associated cytokines in the subject to be reduced in the female subject being administered the SCVMP. In some embodiments, levels of IL-2, IL-5, IL-15, IL-17, and/or IP-10 in the subject are reduced following administration of the SCVMP. In some embodiments, administration of a SCVMP cause elevated levels of Th1 cytokines in the subject to be reduced in the female subject being administered the SCVMP. In some embodiments, administration of a SCVMP cause elevated levels of IFNγ in the subject to be reduced in the female subject being administered the SCVMP. In some embodiments, administration of a SCVMP cause reduced levels of IGF-1, IL-4, IL-10, TGFβ and/or CCL5 in the subject to be increased in the female subject being administered the SCVMP. In some embodiments, administration of a SCVMP cause reduced levels of TGFβ in the subject to be increased in the female subject being administered the SCVMP. Dysbiosis Provided herein are methods of treating dysbiosis of the female genitourinary tract. The methods include administering to a female subject in need of treatment an effective amount of a composition comprising a SCVMP described herein. Subjects treated by the methods described here include females exhibiting an imbalance in the vaginal microbiota that may result in overgrowth of pathogenic microorganisms and pathobionts, resulting in dysbiosis, inflammation, and/or infections. The methods include the treatment of vaginal infections (vaginitis) such as bacterial vaginosis, vaginal candidiasis and trichomoniasis and combinations thereof with composition comprising a SCVMP described herein. Vaginal dysbiosis is a condition in which a female subject exhibiting vaginal dysbiosis has a vaginal microbiome that comprises a relative abundance of bacteria belonging to the genus Lactobacillus that is less than 90% of the (total) detectable bacterial species in a sample of the 80  \\4163‐8733‐4730  v3                microbiota obtained from the genitourinary tract of the female subject. In some embodiments, vaginal dysbiosis refers to a vaginal microbiome having less than 90% relative abundance of the combined abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiment, vaginal dysbiosis refers to a vaginal microbiome having less than 85%, 80%, 70%, 60%, or 50%relative abundance of the combined abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. In some embodiments, a vaginal microbiome is classified as being vaginal dysbiosis if less than 90%, 85%, 80%, 70%, 60%, or 50%of the detectable bacterial species in a sample of the microbiota belong to the genus Lactobacillus selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri. In order to be classified as being dysbiotic, the female subject does not need to exhibit or been diagnosed with having bacterial vaginosis or a fungal infection (e.g., candidiasis). Vaginal dysbiosis is a prevalent condition that occurs in about 30- 40% of female adult subjects. In some embodiments, the dysbiotic female subject does not exhibit any symptoms (asymptomatic). In other embodiments, the dysbiotic female subject suffers from vaginal symptoms characterized by Amsel´s criteria, Nugent score criteria or Hay-Ison criteria. Bacterial vaginosis (BV) is the most common vaginal infection and is associated with complications during pregnancy as well as an increased risk for sexually transmitted diseases. It is caused by an imbalance of naturally occurring bacterial flora, wherein the lactobacilli are overgrown by a mixed flora of anaerobic bacteria. Amongst other diagnostic criteria, a pH greater than 4.5 is thought to be suggestive of bacterial vaginosis. BV may be diagnosed using Amsel criteria, Nugent score, Hay-Ison criteria, or another suitable method of diagnosis. Current treatment options rely on oral or vaginal administration of classical antibiotics such as metronidazole and clindamycin, however there is a high rate of recurrence of over 50% within 3 months after the first exposure. Alternative treatment options include acidification of the vagina with naturally occurring acids such as lactic acid or acetate. In one embodiment, a female subject exhibiting one or more diagnostic signs of BV is treated with an effective amount of a composition comprising a SCVMP described herein. In one embodiment, treatment comprising administration of an effective amount of a composition comprising a SCVMP further comprises a combination therapy (as described herein), including providing standard of care treatment for BV, such as, e.g., administering antibiotics such as metronidazole and clindamycin and/or acidifying the vagina with an acidifying agent, such as, 81  \\4163‐8733‐4730  v3                e.g., lactic acid or acetate, either prior to, concomitant with or after administration of the composition comprising a SCVMP to the female subject. Vaginal candidiasis is a fungal infection of any of the Candida species (yeasts), of which Candida albicans is the most common. Most Candida infections are treatable and result in only minimal complications such as redness or itching. However, complications may also be severe or even fatal if left untreated in certain populations, such as immuno-compromised patients. External use of detergents or internal disturbances (hormonal or physiological) can disturb the normal vaginal flora and result in an overgrowth of Candida cells causing infection. Pregnancy and the use of oral contraceptives have also been reported as risk factors. In clinical settings, candidiasis is commonly treated with antimycotics such as clotrimazole, nystatin, fluconazole and ketoconazole. However, certain yeasts such as, e.g., C. albicans can develop resistance to said antimycotic drugs. In one embodiment, a female subject exhibiting one or more diagnostic signs of candidiasis is treated with an effective amount of a composition comprising a SCVMP described herein. In one embodiment, treatment comprising administration of an effective amount of a composition comprising a SCVMP further comprises a combination therapy (as described herein), including providing standard of care treatment for candidiasis, such as, e.g., administering antimycotics such as, e.g., clotrimazole, nystatin, fluconazole and/or ketoconazole, either prior to, concomitant with or after administration of the composition comprising a SCVMP to the female subject. Trichomoniasis is a sexually transmitted disease of the urogenital tract and is caused by the parasite Trichomonas vaginalis. Symptoms include inflammation of the cervix, urethra and vagina, which produce an itching and burning sensation. Treatment options include the use of antibiotic/anti-protozoal (e.g., metronidazole) or anti-parasitic (e.g., tinidazole) drugs. However, as with most anti-microbial drugs, resistance may occur. In one embodiment, a female subject exhibiting one or more diagnostic signs of Trichomoniasis is treated with an effective amount of a composition comprising a SCVMP described herein. In one embodiment, treatment comprising administration of an effective amount of a composition comprising a SCVMP further comprises a combination therapy (as described herein), including providing standard of care treatment for Trichomoniasis, such as, e.g., administering antimycotics such as, e.g., antibiotic/anti-protozoal (e.g., metronidazole) or 82  \\4163‐8733‐4730  v3                anti-parasitic (e.g., tinidazole) agents, either prior to, concomitant with or after administration of the composition comprising a SCVMP to the female subject. Methods of profiling female subjects Some aspects of the invention involve the use of bacterial profiling of the vaginal microbiome in order to determine whether a female subject undergoing an assisted reproductive technology procedure (e.g., IVF or ICSI) benefits from administration of a SCVMP as described herein. In some embodiments, methods of profiling female subjects involve metagenomic sequencing of a sample of a vaginal microbiome to determine the relative abundance of Lactobacillus species (e.g., Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri). Determination that the relative abundance of Lactobacillus species (e.g., Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri) is less than 95%, less than 90%, less than 85%, or less than 80% of all detectable bacterial species in sample of the vaginal microbiome indicates that the subject is exhibiting vaginal dysbiosis and thus would benefit from administration of a SCVMP as described herein. In some embodiments, the method comprises (a) obtaining a sample of the microbiota of the genitourinary tract of the subject; (b) profiling the species content of the sample; (c) determining the relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri within the sample, wherein the subject benefits from administration of a composition if the relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri is less than 95%, less than 90%, less than 85%, or less than 80% of the total abundance of all detectable bacterial species of the sample, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. In other aspects of the invention, provided herein are methods of determining whether a subject undergoing an assisted reproductive technology procedure benefits from administration of a SCVMP. It has been shown by the inventors that IVF success can be partially attributed to two or fewer prior assisted reproductive technology (e.g., IVF) cycles; an age of the subject being about 42 or less; and/or two or fewer previous pregnancy losses (e.g., miscarriages). It has 83  \\4163‐8733‐4730  v3                been shown that administration of a SCVMP can further enhance likelihood of IVF success within a cohort of female subjects with two or fewer prior assisted reproductive technology (e.g., IVF) cycles; an age of the subject being about 42 or less; and/or two or fewer previous pregnancy losses (e.g., miscarriages). Thus, in some embodiments, provided herein is a method comprising determining one, two, or three of: (a) the number of prior assisted reproductive technology (e.g., IVF) cycles attributable to the subject; (b) the age of the subject; and/or (c) the number of previous pregnancy losses suffered by the subject; wherein the subject benefits from administration of a composition if the number of prior assisted reproductive technology (e.g., IVF) cycles is two or fewer; the age of the subject is about 42 or less; and/or the number of previous pregnancy losses is two or fewer, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, or three bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. In some embodiments, a method involves determining (a) the number of prior assisted reproductive technology (e.g., IVF) cycles attributable to the subject; and (b) the age of the subject. In some embodiments, a method involves determining (a) the number of prior assisted reproductive technology (e.g., IVF) cycles attributable to the subject; and (c) the number of previous pregnancy losses suffered by the subject. In some embodiments, a method involves determining (b) the age of the subject; and (c) the number of previous pregnancy losses suffered by the subject. In some embodiments, a method involves determining each of (a) the number of prior assisted reproductive technology (e.g., IVF) cycles attributable to the subject; (b) the age of the subject; and (c) the number of previous pregnancy losses suffered by the subject. DEFINITIONS The definitions hereinafter apply to all aspects disclosed herein. For example, the term “substantially complete vaginal microbiota preparation(s)” shall have the same meaning when used in the context of the first aspect which pertains to vaginal delivery system, or when used in the context of the second aspect which pertains to pharmaceutical composition, or when used in the context of any other aspect disclosed herein. “Substantially complete vaginal microbiota preparation(s)” may be abbreviated as SCVMP. 84  \\4163‐8733‐4730  v3                Unless otherwise explained, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It is further to be understood that methods and materials similar or equivalent to those described herein can be used in the practice or testing of this disclosure. The materials, methods, and examples are illustrative only and not intended to be limiting. Other features of the disclosure are apparent from the following detailed description and the claims. The singular terms “a,” “an,” and “the” include plural references unless context clearly indicates otherwise. Similarly, the word “or” is intended to include “and” unless the context clearly indicates otherwise. The term “comprises” means “includes.” The abbreviation, “e.g.” is derived from the Latin exempli gratia, and is used herein to indicate a non-limiting example. Thus, the abbreviation “e.g.” is synonymous with the term “for example.” The term “optional” or “optionally” means that the subsequent described event, circumstance or substituent may or may not occur, and that the description includes instances where the event or circumstance occurs and instances where it does not. Unless otherwise indicated, all numbers expressing quantities of components, times, and so forth, as used in the specification or claims are to be understood as being modified by the term “about.” Accordingly, unless otherwise implicitly or explicitly indicated, or unless the context is properly understood by a person of ordinary skill in the art to have a more definitive construction, the numerical parameters set forth are approximations that may depend on the desired properties sought and/or limits of detection under standard test conditions/methods as known to those of ordinary skill in the art. In a preferred embodiment, the term “about” shall allow a deviation of + 10%, and even more preferably of + 5% from an indicated numerical value. The term “comprising” shall be understood to simultaneously also disclose the term “consisting” as a preferred option. For example, if a composition is said to comprise three components, this also discloses a composition consisting of these three components as preferred embodiment. If the term “comprising” is used when referring to (a) pharmaceutically active compound(s), bacterium(a), and the like, this shall be understood to simultaneously also disclose that the pharmaceutically active compound(s), bacterium(a), and the like is/are preferably the sole pharmaceutically active compound(s), bacterium(a), and the like. For example, if a donor 85  \\4163‐8733‐4730  v3                sample is said to comprise Lactobacillus crispatus and Lactobacillus jensenii, this simultaneously discloses that a donor sample contains Lactobacillus crispatus and Lactobacillus jensenii as the sole bacteria. If a donor sample is said to comprise Lactobacillus crispatus, Lactobacillus jensenii, and an excipient, this simultaneously discloses that a donor sample contains Lactobacillus crispatus and Lactobacillus jensenii as the sole bacteria and in addition comprises an excipient. It further discloses, that the donor sample consists of Lactobacillus crispatus, Lactobacillus jensenii, and an excipient. All patents, patent applications, and publications identified are expressly incorporated herein by reference for the purpose of describing and disclosing, for example, the methodologies described in such publications that might be used in connection with the present invention. “Genitourinary tract” or “urogenital tract” as used herein includes the uterus, fallopian tubes, ovaries, vagina, cervix, vulva, endometrium, and urinary tract. In some instances, used herein are teachings and exemplifications specifically calling out the “vaginal tract”, “vaginal cavity” “reproductive tract” or “vagina”. In some embodiments, the genitourinary tract comprises the reproductive tract. One of ordinary skill will appreciate that these exemplifications and teachings are illustrative only and non-limiting and, thus also apply, where appropriate, to other anatomical sites of the genitourinary tract or urogenital tract, not just to the vagina. “Dysbiosis” as used herein means a microbial imbalance where normally predominant species are diminished in abundance and less predominant species become more abundant and/or predominant. Vaginal dysbiosis is a microbial imbalance in the vagina, an aberration of the healthy state. Dysbiosis is generally associated with one or more of: (a) qualitative and quantitative changes in the content or amount of the microbiota itself, (b) changes in their metabolic activities; and/or (c) changes in their local distribution. A dysbiotic human vaginal microbiota balance refers to a population of vaginal microbes that promotes inflammation of a tissue of the vagina and/or that contributes to or establishes an environment that permits or promotes the colonization or growth of one or more pathogenic microbes. Dysbiosis also refers to a perturbation of vaginal homeostasis. In some embodiments, a dysbiotic vaginal microbiota will generally result in increased pH relative to a healthy microbiota, e.g., a pH above 4.5, e.g., a pH of 5.0, 5.5, 6.0, 6.5, 7.0 or higher. In some embodiments, vaginal dysbiosis is characterized by a reduction of Lactobacillus spp., and an increased diversity of vaginal anaerobic bacteria. Vaginal dysbiosis is associated with upper genital tract infections or pelvic inflammatory disease 86  \\4163‐8733‐4730  v3                (PDI), and increased risk of sexual transmitted diseases. Dysbiosis may be characterized by the relative amount of selected pathogens, such as >20% selected pathogens, and the relative low abundance of vaginal lactobacilli, e.g. <10% vaginal lactobacilli (L. crispatus, L. iners, L. jensenii, L. gasseri). In some embodiments, vaginal dysbiosis is defined as a vaginal microbiome having less than 95% (e.g., less than 90%, 85%, 80%, or 75%) relative abundance of three selected Lactobacillus species – Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii. Dysbiotic subjects as used herein comprise subjects having vaginal symptoms (symptomatic subjects) and subjects not having any vaginal symptoms (asymptomatic subjects), wherein symptoms are characterized by Amsel´s criteria, Nugent score and/or Hay/Ison score. In contrast, the term “normal” or “healthy” “vaginal flora” or “vaginal niche” “microbiota” or “state” or similar terms connote that a woman has no vaginal complaints and does not exhibit a vaginal pathology (e.g., no sign or symptom corresponding to or resulting from a pathology of the vagina), and the condition of the vagina is such of a relatively low susceptibility to sexually transmitted diseases and pathogens, and generally of low pH, e.g., less than or equal to pH 4.5, e.g., between 3.2 and 4.5; and generally dominated by lactic acid producing bacteria (e.g., Lactobacillus spp.). Normal vaginal microbiota or normal flora are a community of microorganisms that localize to the vagina in a normal, healthy, that is, a non- pathological, non-pathogenic and/or non-dysbiotic, state. “Cervicovaginal secretions” (“CVS”) or “vaginal fluid” or “vaginal mucosal sample” refers to the mixture of mucus secreted by the cervix, shed epithelial cells, vaginal transudate, and bacteria found in the vagina of a woman. “Isolated bacterial strain” means a strain that has been separated from other strains (e.g., from a vaginal bacterial community, e.g., derived from a sample of cervicovaginal secretions or vaginal fluid) and cultivated in vitro in a culture comprising said strain. An isolated bacterial strain is substantially free of contaminants or components that accompany the material it was derived from in its native state (e.g., such as, vaginal mucus and epithelial cells). “Culture-independent method” means methods not involving isolation and/or in vitro propagation of bacterial strains, e.g., in cultures. A substantially complete vaginal microbiota preparations (SCVMP) is, in some embodiments, obtained using a culture-independent method (e.g., as described herein, e.g., donor-derived, such as CVS). 87  \\4163‐8733‐4730  v3                The term “microbe” is used synonymously with the term “microorganism” and includes bacteria (Archaea, Eubacteria), yeast, fungi, and viruses. The term “species” is used herein to refer to a taxonomically and/or genetically distinct group of microorganisms. Species may include one or more distinguishable (e.g., by sequencing) strains. The term “microbiota” refers to a community of microorganisms localized to a distinct shared environment (a “microbial niche”). For example, “vaginal microbiota” is a community of one or more species of microorganisms that are localized to, or found in, a vagina. The term “microflora” or “flora” is used synonymously with the term “microbiota.” Healthy or normal microbiota denominates the community of commensal microorganisms that colonize (inhabit) a particular microbial niche of the host, such as the vagina. Bacteria are the most numerous microbial components of the normal flora. “Mucosa” as used herein indicates a mucous membrane. Mucus is a secretion produced by, and covering, mucous membranes. Mucous fluid is viscous and typically produced from mucous cells (e.g., goblet cells) found in mucous membranes and submucosal glands, and rich in antiseptic enzymes (such as lysozyme), immunoglobulins, inorganic salts, proteins such as lactoferrin, and glycoproteins (mucins). Mucosal surfaces include epithelial linings of the reproductive tract (vagina) and, e.g., lactobacilli are capable of colonizing the vaginal mucosal surfaces. As used herein, the term “effective amount” means the amount (e.g., of a composition or preparation) to be administered to a typical subject (e.g., a female recipient) that is sufficient to lead to a desired beneficial or therapeutic effect in the subject. The desired beneficial or therapeutic effect includes prophylaxis and/or treatment, e.g., of dysbiosis, inflammation or an infection or urogenital tract, and also includes the restoration and/or rebalancing of the vaginal microbiota (e.g., to achieve homeostasis), e.g., an anti-inflammatory and/or anti-pathogenic state of the urogenital tract and the vaginal microbiota. An effective amount, for example, is the amount sufficient (e.g., at dosages and for periods of time necessary) to alleviate at least one or more symptom, delay the development of a symptom, alter the course of a symptom (e.g., slowing the progression of a symptom), or reverse a symptom. Effective amounts generally cause statistically significant, measurable changes. The effective amount in a delivery system varies depending on the particular agent, intended use, expected release rate and the time for which the system is expected to provide 88  \\4163‐8733‐4730  v3                therapy. A variety of devices with varying sizes can be formulated for administering dosages. A person skilled in the art is readily able to determine the effective amount of the active agent needed for each specific application and delivery system. Effective amounts can be determined, e.g., in clinical trials and animal studies. The term “effective amount” is used interchangeably with the term “therapeutically effective amount”. A “lyophilized” or “freeze-dried” composition refers to a composition from which moisture has been removed, e.g., for easy storage and transport. Such compositions can be rehydrated before use (e.g., administration). As used herein, the term “viable” refers to a cell (e.g., a bacterial cell) that is able to survive in a given condition (e.g., storage for a certain period of time under particular storage conditions, e.g., including, temperature, humidity) and is generally able to colonize and reproduce (e.g., in the urogenital tract) after exposure to the condition. Percent viability refers to the percentage of viable cells in a population. For example, percent viability can refer to the percentage of lactobacilli in a pharmaceutical composition that will survive (e.g., refrigeration, freezing and/or storage) and colonize upon application to a vaginal mucosal surface. The abbreviation “cfu” means “colony-forming unit”. The abbreviation “VCC” means viable cell count (as determined by life cell staining). The phrases “excipient” “pharmaceutically acceptable carrier” “diluent” or “buffer” as used herein mean a non-active, pharmaceutically acceptable material, ingredient, composition or vehicle that is added to form part of the final formulation and/or maintains a drug or other agent in a form for delivery to a subject. Each carrier preferably is compatible with the other ingredients of the formulation, for example the carrier does not decrease the impact of an active ingredient or agent upon the treatment, e.g., the carrier is pharmaceutically inert. In some embodiments a pharmaceutically acceptable carrier can be a carrier other than water (including, e.g., a cream, emulsion, gel, liposome, nanoparticle, film, ointment and/or vaginal device). In some embodiments, a pharmaceutical composition is provided comprising the SCVMPs together with a pharmaceutically acceptable carrier and/or diluent (e.g., saline). These compositions allow the easy administration of the preparations by means known to the person skilled in the art. In some embodiments, a buffering agent is added, e.g., a weak acid or base that maintains the acidity at a chosen level (e.g., between pH 3.5 and 4.5) and prevents a rapid change in acidity. 89  \\4163‐8733‐4730  v3                The terms “contacting”, “administering” or “subjecting” and more specifically, “vaginal application” or “vaginal administration”, are used interchangeably herein and relate to a subject (e.g., a female recipient) or a specific organ or other physiological site (e.g., the urogenital tract or vaginal cavity or a subpart thereof, e.g., to a site on a vaginal wall (mucosal or endometrial surfaces) or vaginal fornices) and a device, dosage form or pharmaceutical composition that is provide or given to the subject or site, e.g., for the purpose of colonizing and engrafting a desired bacterial community (e.g., comprising lactobacilli), e.g., as comprised in the SCVMPs described herein. In one embodiment, administering is performed locally. In one embodiment, administering is performed vaginally, e.g., to improve vaginal health, e.g., in the context of treatment of a disease or disorder. As used herein, the terms “pharmaceutical composition” or “therapeutic composition” refer to the active agent (e.g., the SCVMPs described herein) in combination with a pharmaceutically acceptable carrier, e.g., a carrier commonly used in the pharmaceutical industry, or an additional active agent. Pharmaceutical compositions are physiologically and pharmacologically acceptable. Generally, compounds, materials (devices), compositions, and/or dosage forms are “pharmaceutical” “therapeutic” or “pharmaceutically acceptable” if they are, within sound medical judgment (e.g., by a physician or regulatory agency), suitable for use in contact with the tissues of human beings without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio (e.g., desired benefit(s) versus side effects (adverse events)). A pharmaceutical composition will generally comprise agents for buffering and preservation in storage, and can include buffers and carriers for appropriate delivery, depending on the route of administration. Pharmaceutical compositions can be conventionally administered in a unit dose. The term “unit dose” refers to physically discrete units suitable as unitary dosage for the subject, each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect in association with the required physiologically acceptable diluent, i.e., carrier, or vehicle. The terms “dose” and “dosage” are used interchangeably herein. A dose refers to the amount of active ingredient given to an individual at each administration. The dose will vary depending on a number of factors, including frequency of administration (e.g., daily, one or more times per week, per month, or per 3 months); size and tolerance of the individual; severity of the condition; intended result (e.g., treatment, prophylaxis, modulation or restoration of the 90  \\4163‐8733‐4730  v3                microbial community), and the route of administration. A baseline dose can be administered and modified based on the initial response of the subject. For example, a single dose of the compositions comprising the SCVMPs described herein can be in the range of 10 4 to 10 10 , 10 4 to 10 11 , or 10 4 to 10 12 colony forming units (per dose). In other embodiments, a single dose of the composition can be in the range of 10 3 to 10 12 , 10 4 to 10 9 , 10 5 to 10 9 , 10 5 to 10 8 , 10 6 to 10 9 , 10 7 to 10 9 , or 10 7 to 10 10 colony forming units (per dose). In some embodiments, a single dose of the composition is at least 10 4 or at least 10 5 colony forming units (per dose). In some embodiments, one dose of the composition is administered to the subject. A “dosage form” refers to a particular physical form of a pharmaceutical composition and depends, e.g., on the dose required to deliver a desired amount of an active agent and on the route of administration. For example, a dosage form can be in a suppository, a tablet, a capsule, a film, a cream, etc., or a device, such as, e.g., an applicator or dispenser, e.g., for vaginal administration. Dosage forms may be single or multiple-use dosage forms. As used herein, the terms “treat,” “treatment,” “treating” refer to prophylactic and therapeutic treatments, wherein the object is to prevent, reverse, alleviate, ameliorate, inhibit, slow down or stop the progression or severity of a condition or symptom of a condition associated with a disease or disorder. Treatment of infertility may refer to treatment of one or more symptoms or conditions associated with infertility. In some embodiments, treatment of infertility refers to treatment of an inflammation-associated cause of infertility. In some embodiments, treatment of infertility refers to treatment of dysbiosis in the vaginal microbiome or inflammation in the vagina. Treatment includes the improvement of symptoms or markers (of the disease or condition) and the cessation or at least slowing of progress or worsening of symptoms that would be expected in absence of treatment. Treatment effectiveness can be measured by monitoring one or more symptoms or clinical markers and is compared, e.g., to the subject’s condition and symptoms before administration or to a control subject not undergoing treatment. In one example, treating a vaginal infection refers to reducing the amount of the infective agent (e.g., number of cells or viral particles), reducing the severity of symptoms, and/or reducing the frequency of symptoms. A treatment that reduces the level of a pathogen to one which is kept in check by the immune system or by the state established by a healthy vaginal microbiota (e.g., the infection is no longer detectable, e.g., by symptoms or general diagnostic techniques) is considered effective as the term is used herein. 91  \\4163‐8733‐4730  v3                As used herein, the term “colonization” or “engraftment” refers to the colonization of an environment (e.g., a microbial niche), e.g., the vagina or vaginal epithelium, by a microbe, e.g., a bacterium (e.g., lactobacilli), such that the viable population of that microbe continues to reside, e.g., in the niche, for a certain period of time. Engraftment can be transient or stable depending on the period of time the microbe continues to reside in the niche. Colonization and engraftment (and residence time) can be quantified, e.g., by counting the number of colony forming units (CFU)/gram and/or performing nucleic acid sequencing of microbes comprised in one or more vaginal samples that are taken over a certain period of time. The term “subject” refers to a human (e.g., a human female) subjected to a treatment, observation or study. In one embodiment, the subject is a recipient of a composition comprising the SCVMP described herein, e.g., a recipient female. In one embodiment, the subject is a donor female providing a microbial sample. In some embodiments, the subject has one or more of the inflammation-associated infertility conditions. In some embodiments, the subject has bacterial vaginosis (BV). In some embodiments, the subject has pelvic inflammatory disease (PID). In some embodiments, the subject has tubal factor infertility. In some embodiments, the subject has endometriosis. In some embodiments, the subject has polycystic ovary syndrome (PCOS). In some embodiments, the subject has idiopathic (unexplained) infertility. In some embodiments, the subject has endometrial infertility, which results from endometriosis. In some embodiments, the subject is undergoing an assisted reproductive procedure (e.g., in vitro fertilization). In some embodiments, the female subject is undergoing intrauterine insemination or treatments to stimulate egg production. A subject who is “undergoing fertility treatments” or “undergoing IVF” may be a subject who is preparing or planning to begin fertility treatments or IVF. A subject may be an asymptomatic dysbiotic female subject (e.g., having a dysbiotic vaginal microbiome but is not exhibiting symptoms (e.g., clinical symptoms) of bacterial vaginosis or a vaginal infection (e.g., a vaginal yeast infection)). In some embodiments, the female subject is an asymptomatic dysbiotic female subject, or the population of female subjects is a population of asymptomatic dysbiotic female subjects. The female subject may be 15-34 years of age, 35-50 years of age, 51-75 years of age, 15-44 years of age, 35-44 years of age, or 45 or more years of age. The female subject may be 20-45 or 20-42 years of age In some embodiments, the subject is a pre-menopausal female subject. In some embodiments, the subject is suffering from recurrent implantation failure (RIF). 92  \\4163‐8733‐4730  v3                The terms “infertile” or “infertility” refer to a subject who is unable to become pregnant. In some embodiments, an infertile subject is an infertile female subject who is unable to become pregnant over a defined period of time while having unprotected sexual intercourse (e.g., regular unprotected sexual intercourse) with a male subject. In some embodiments, an infertile subject is an infertile female subject who is unable to become pregnant over twelve months while having unprotected sexual intercourse (e.g., regular unprotected sexual intercourse) with a male subject. In some embodiments, an infertile subject is an infertile female subject who is unable to become pregnant over six months while having unprotected sexual intercourse (e.g., regular unprotected sexual intercourse) with a male subject. A female subject is having unprotected sexual intercourse with a male subject if the female and male subjects are not using a form of birth control or are improperly using a form of birth control while having sexual intercourse (e.g., penile-vaginal intercourse or any form of sexual intercourse that causes sperm to come into contact with the vagina or genitourinary tract). In some embodiments, an infertile female subject is any female subject who wants to become pregnant but cannot. In some embodiments, an infertile female subject cannot become pregnant because the female subject is biologically infertile. In some embodiments, an infertile female subject cannot become pregnant because the female subject is having sexual intercourse with a man who is biologically infertile. In some embodiments, an infertile female subject cannot become pregnant because the female subject is not having sexual intercourse with any men (e.g., because the female subject is asexual, a lesbian, abstinent). In some embodiments, an infertile female subject may utilize donated eggs and/or donated sperm as a component of their infertility treatment. The terms “increased”, “increase”, “enhance”, or “activate” can mean an increase of at least 10% as compared to a reference level, for example an increase of at least about 20%, or at least about 30%, or at least about 40%, or at least about 50%, or at least about 60%, or at least about 70%, or at least about 80%, or at least about 90% or up to and including a 100% increase or any increase between 10-100% as compared to a reference level, or at least about a 2-fold, or at least about a 3-fold, or at least about a 4-fold, or at least about a 5-fold or at least about a 10- fold increase, or any increase between 2-fold and 10-fold or greater as compared to a reference level. The terms “lower”, “reduced”, “reduction” or “decrease”, “down-regulate” or “inhibit” mean a decrease by at least 10% as compared to a reference level, for example a 93  \\4163‐8733‐4730  v3                decrease by at least about 20%, or at least about 30%, or at least about 40%, or at least about 50%, or at least about 60%, or at least about 70%, or at least about 80%, or at least about 90% or up to and including a 100% decrease (i.e. absent level (or levels below the limit of detection) as compared to a reference sample), or any decrease between 10-100% as compared to a reference level. The term “substantially” means to a great or significant extent. For example, in the case of a sample that is “substantially free of” pathogens, the term means the sample is, for the most part, or essentially, but possibly not completely, void of a pathogen. A sample that is substantially free of selected pathogens can refer to a sample that comprises about 5%, <5%, <4%, <3%, <2%, or <1% of the selected pathogens. In a particular embodiment, the term “substantially free” comprises <5% The term “inflammation”, “inflammatory disorder”, “diseases associated with inflammation”, “conditions associated with inflammation” are used interchangeably and describe any condition, disorder, disease or state that comprise or are characterized by inflammation. The inflammation may be an acute inflammation or a chronic inflammation. The term “embryo implantation” refers to the successful implantation of the blastocyst embryo into the receptive endometrial (uterine) lining. The term “pregnancy” can refer to biochemical pregnancy or clinical pregnancy. A biochemical pregnancy is defined, in some embodiments, as a positive Human Chorionic Gonadotropin (beta-CG) test (e.g., in the blood of the female subject) at a defined period after embryo transfer or conception (e.g., 2 weeks after embryo transfer). A clinical pregnancy is defined, in some embodiments, by the presence of at least one gestational sac (e.g., intrauterine gestational sac) at a defined time point (e.g., 5-6 weeks after embryo transfer or conception). The term “control population” refers to a population of human subjects who are not within the active treatment population. In some embodiments, a control population is (i) a population of female subjects (e.g., infertile female subjects) who are not being administered the SCVMP (e.g., and are actively engaged in the same set of fertility treatments, e.g., IVF); (ii) a population of female subjects who are not being administered the SCVMP (e.g., and are actively engaged in unprotected sexual intercourse with a male); (iii) a population of fertile female subjects who are not being administered the SCVMP (e.g., and are actively engaged in unprotected sexual intercourse with a male); or (iv) the same population of female subjects not 94  \\4163‐8733‐4730  v3                being administered the SCVMP during a period of time (e.g., 6 or 12 months) prior to the administration of the preparation. The term “in vitro fertilization (IVF) cycle” refers to a first IVF cycle and subsequent IVF cycles. A first IVF cycle involves stimulation of the female subject to produce one or more eggs, extraction the produced eggs, fertilization of the eggs with sperm, and then a transfer of one or more of the fertilized eggs to the uterus of the female subject. A subsequent IVF cycle may be a frozen embryo transfer (FET). In some embodiments, a subsequent IVF cycle involves a second, third, fourth, fifth, or more round of: stimulation of the female subject to produce one or more eggs, extraction of the produced eggs, fertilization of the eggs with sperm, and then a transfer of one or more of the fertilized eggs to the uterus of the female subject. The term “predetermined” is used herein to denote threshold values of (i) levels of a (one or more) pathogen, as desired (e.g., a tolerated maximum amount, e.g., as considered safe for a recipient subject, e.g., as determined by regulatory bodies such as FDA and EMA); (ii) a level of microbial viability and/or quantity, e.g., of desired vaginal microbes, e.g., a minimum level in a given composition or dosage form, e.g., determined to be required to make up the minimum effective dose for a treatment described herein ( e.g., upon processing of the CVS, a minimum of 50%, 60%, 70% or more of cells remain viable in a composition, or a desired total value of CFU/VCC in the composition comprising the SCVMP as described herein, or a desired total concentration in the composition, e.g., as expressed in CFU/ml or VCC/ml); (iii) a predetermined weight or volume of the composition, e.g., wherein the desired weight or volume is determined by the form, shape, size of the dosage form and/or the desired concentration (e.g., CFU/ml) or total microbial content (e.g., CFU or VCC) for an effective dose. The predetermined values may be selected to standardize the substantially complete vaginal microbial preparation, dosage forms and pharmaceutical compositions comprising the same. In some embodiments, the standardization (e.g., by using the predetermined values and thresholds described herein and then releasing the composition for use) is required for, e.g., manufacturing under good manufacturing practice (GMP) and/or regulatory approval, e.g., by a regulatory body, such as FDA and EMA, e.g., as a regulated product, such as a product regulated under pharmaceutical or cell and tissue regulations. Other predetermined values described herein can include, e.g., pH, osmolarity and/or viscosity of the compositions as desired, e.g., to improve efficacy, mode and/or ease of administration, etc. Predetermined level/absence of pathogens: Assessing the pathogens that may 95  \\4163‐8733‐4730  v3                be comprised in the substantially complete vaginal microbial preparation ensures that the composition is suitable to be administered to exert a beneficial effect on the recipient subject, and does not causes an infection in the recipient subject. In some embodiments, the method of obtaining the substantially complete vaginal microbial preparation thus comprises a step of assessing the level of pathogens and releasing the composition only if a predetermined level of pathogens is obtained. The predetermined level of pathogens may be the absence of substantially absent level of pathogens. In some embodiments, the predetermined level of pathogens allows up to 5%, 4%, 3%, 2%, 1%, or 0.5% pathogens of the microbial composition to be comprised. The predetermined levels of the pathogens are not effective or causative for an infection in a recipient subject. In some embodiments, the pathogens comprise pathobionts, which can be commensal in nature but can also become pathogenic (e.g., can cause or promote disease) when certain genetic and/or environmental conditions are present in a subject. In some embodiments, the predetermined level of pathobionts is <30%, <20%, <10%, <5%, <2%, <1%, <0.5%, or <0.1% pathobionts in the substantially complete vaginal microbial preparation. Predetermined viability and/or quantity of vaginal or urogenital microbes: The method of obtaining the substantially complete vaginal microbial preparation may comprise a step of assessing the viability and/or quantity of vaginal or urogenital microbes comprised in the preparation, and releasing the preparation only if a predetermined level of viability and/or quantity of the vaginal or urogenital microbes is obtained. In some embodiments, the predetermined viability and/or quantity may be assessed with live/dead staining or by determining colony forming units or viable cell counts (CFUs or VCCs). In some embodiments, the predetermined viability is 10 3 to 10 15 colony forming units or viable cell counts (CFUs or VCCs), 10 4 to 10 11 CFUs/mL or VCCs/mL, 10 5 to 10 11 CFUs/mL or VCCs/mL, or 10 6 to 10 11 CFUs/mL or VCCs/mL. In some embodiments, the predetermined viability is a threshold value of 50%, 60%, 70% or more viable cells in the substantially complete vaginal microbial preparation. Predetermined level of pH: The vaginal mucosal pH is a clinical parameter that in subjects with vaginal dysbiosis or BV is more alkaline than in healthy subjects. Healthy, fertile women present with a pH of about 3 to 5.5 (more specifically between pH 3.5 and 4.5) in the vagina, primarily as a result of lactic acid production. The increase of vaginal pH above 4.0-4.5 is detrimental for the survival of Lactobacillus bacteria. In some embodiments, the vaginal mucosa of subjects having vaginal dysbiosis or BV is greater than pH 4.5, e.g., pH 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, or greater and is adjusted to 96  \\4163‐8733‐4730  v3                predetermined levels by administration with the substantially complete vaginal microbial preparation provided herein. The method of obtaining the substantially complete vaginal microbial preparation may comprise a step of adjusting the pH of the preparation and or the vaginal niche to a predetermined level, wherein the predetermined level is pH 3.0 – 4.5, optionally pH 3.5-4.0. In some embodiments, the pH is adjusted to 3.0-4.5, 3.2-4.3, 3.4-4.3, 3.5- 4.0, or about 3.7-4.0. In some embodiments, the predetermined level is approximately pH 3.5- 4.0. In some embodiments, the pH is adjusted to the predetermined pH level by addition of acids, such as lactic acid according to routine methods in the art. Predetermined level of viscosity: Cervicovaginal fluid is a viscous fluid, wherein the level of viscosity is variable and depends, inter alia, on the rate of mucociliary transport, the water content and the amount of glycoproteins or mucins present in the fluid. The viscosity of a fluid can be determined with any known methods in the art, such as a rheometer or viscosimeter. The method of obtaining the substantially complete vaginal microbial preparation may comprise a step of adjusting the viscosity to a predetermined level. This enables that the substantially complete vaginal microbial preparation can be aliquoted or stored in uniform and homogenous units. In some embodiments, the method of obtaining a substantially complete vaginal microbial preparation comprises a step of adjusting the viscosity to a predetermined level of ≤1000 cP, ≤750 cP, or ≤500 cP. In some embodiments, the predetermined level is approximately 1-500 cP, 1-400 cP, 1-300 cP, 1-200 cP, 1-100 cP, 1-50 cP, or 1-25 cP. In some embodiments, the predetermined level is approximately 1-100 cP or 1-50 cP. Predetermined level of osmolarity: Adjusting the osmolarity of the substantially complete vaginal microbial preparation ensures that the osmolarity and thus fluid homeostasis in the urogenital or vaginal tract is not perturbed. In some embodiments, the method of obtaining the substantially complete vaginal microbial preparation may comprise a step of adjusting the osmolarity to a predetermined level. In some embodiments, the predetermined level of osmolarity of the substantially complete vaginal microbial preparation is set to 200-500 mOsm/kg, such as 220-480 mOsm/kg, 250-450 mOsm/kg, 300-400 mOsm/kg, or 320-380 mOsm/kg. Osmolarity may be determined by methods known in the art, e.g., using a vapor pressure osmometer; and adjusted by addition of e.g., water to reduce osmolarity, or by addition of an excipient, such as mannitol, to increase osmolarity. ADDITIONAL EMBODIMENTS 97  \\4163‐8733‐4730  v3                Additional embodiments of the present disclosure are encompassed by the following numbered paragraphs/enumerated embodiments: 1. A composition for use in a method of treating infertility in an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract, said method comprising administering to the subject an effective amount of the composition to the genitourinary tract to treat infertility, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. 2. A composition for use in a method of treating inflammation in the genitourinary tract of an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract, said method comprising administering to the subject an effective amount of the composition to treat inflammation in the genitourinary tract, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. 3. A composition for use in a method of treating dysbiosis in the genitourinary tract of an infertile female subject exhibiting a dysbiotic microbiota in the genitourinary tract, said method comprising administering to the subject an effective amount of the composition to treat the dysbiosis in the genitourinary tract, wherein the composition comprises a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. 4. A composition for use in a method of promoting embryo implantation in a population of female subjects, optionally a population of infertile female subjects, wherein each of the subjects in the population exhibits a dysbiotic microbiota in the genitourinary tract, said method 98  \\4163‐8733‐4730  v3                comprising administering to each of the subjects an effective amount of the composition to the genitourinary tract to promote embryo implantation, wherein the composition comprises: a substantially complete vaginal microbiota preparation comprising: (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80- 99.9% of all detectable bacterial species of the preparation; and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; and wherein embryo implantation is promoted when the rate of embryo implantation is increased in the population of female subjects being administered the composition relative to a control population. 5. The composition for use of any one of embodiments 1-4, wherein the infertile female subject is exhibiting one or more infertility conditions, or the population of infertile female subjects is a population of subjects exhibiting one or more conditions associated with infertility. 6. The composition for use of embodiment 5, wherein the one or more conditions associated with infertility is selected from the group consisting of: pelvic inflammatory disease (PID), endometritis, idiopathic infertility, tubal factor infertility, endometriosis, and polycystic ovary syndrome (PCOS). 7. The composition for use of embodiment 5 or 6, wherein the one or more conditions associated with infertility is pelvic inflammatory disease (PID). 8. The composition for use of embodiment 5 or 6, wherein the one or more conditions associated with infertility is endometritis. 9. The composition for use of embodiment 5 or 6, wherein the one or more conditions associated with infertility is idiopathic infertility. 10. The composition for use of embodiment 5 or 6, wherein the one or more conditions associated with infertility is tubal factor infertility. 11. The composition for use of embodiment 5 or 6, wherein the one or more conditions associated with infertility is endometriosis. 12. The composition for use of embodiment 5 or 6, wherein the one or more conditions associated with infertility is polycystic ovary syndrome (PCOS). 13. The composition for use of any one of embodiments 4-12, wherein the method increases the rate of biological pregnancies in a population of female subjects, relative to a control population, 99  \\4163‐8733‐4730  v3                optionally wherein the population of female subjects comprises at least 10, at least 20 or at least 40 female subjects. 14. The composition for use of any one of embodiments 1-13, wherein the female subject is an asymptomatic dysbiotic female subject, or the population of female subjects is a population of asymptomatic dysbiotic female subjects. 15. The composition for use of any one of embodiments 1-14, wherein the subject(s) is/are 15-34 years of age. 16.The composition for use of embodiment 15, wherein the subject(s) has/have been unable to conceive after 12 months of unprotected sexual intercourse with one or more men. 17.The composition for use of any one of embodiments 1-14, wherein the subject(s) is/are 35-50 years of age. 18. The composition for use of any one of embodiments 1-14, wherein the subject(s) is/are 51-75 years of age. 19. The composition for use of embodiment 17 or 18, wherein the subject(s) has/have been unable to conceive after 6 months of unprotected sexual intercourse with one or more men. 20. The composition for use of any one of embodiments 1-14, wherein the subject(s) is/are a pre- menopausal female subject. 21. The composition for use of any one of embodiments 1-20, wherein the subject(s) is suffering from recurrent implantation failure (RIF). 22.The composition for use of any one of embodiments 1-21, wherein the infertile female subject is undergoing an assisted reproductive procedure, or the population of infertile female subjects is a population of subjects undergoing an assisted reproductive procedure. 23. The composition for use of embodiment 22, wherein the assisted reproductive procedure is in vitro fertilization. 24. The composition for use of any one of embodiments 1-21, wherein the infertile female subject is undergoing intrauterine insemination or treatments to stimulate egg production, or the population of infertile female subjects is a population of subjects undergoing intrauterine insemination or treatments to stimulate egg production. 25. The composition for use of any one of embodiments 1-24, wherein the composition is formulated into a dosage form; wherein the dosage form comprises an effective amount of the composition in one or more discrete units, wherein the effective amount is predetermined. 100  \\4163‐8733‐4730  v3                26. The composition for use of any one of the preceding claims, wherein the female subject is not treated with an antibiotic prior to administration of the composition. 27. The composition for use of any one of the preceding embodiments, wherein the composition is administered to the vaginal cavity of the subject. 28. The composition for use of embodiment 27, wherein prior to administering the composition, a vaginal wash is performed and/or wherein the vaginal wash is subsequently rinsed with saline and/or lactic acid. 29. The composition for use of embodiment 28, wherein the vaginal wash is performed with saline, lactic acid or an antiseptic agent, optionally wherein the antiseptic agent is povidone- iodine or chlorohexidine. 30. The composition for use of any one of embodiments 1-25 or 27-29, wherein (a) the subject has been diagnosed with bacterial vaginosis or a vaginal infection, and wherein the female subject is pre-treated with an antibiotic prior to administration of the composition; or (b) wherein the subject has not been diagnosed with bacterial vaginosis or a vaginal infection, wherein the female subject is not pre-treated with an antibiotic prior to administration of the composition. 31. The composition for use of any one of the preceding embodiments, wherein the female subject exhibits endometrial and/or vaginal inflammation. 32. The composition for use of embodiment 31, wherein the subject has elevated vaginal levels of pro-inflammatory or inflammasome-associated cytokines. 33.The composition for use of embodiment 32, wherein the pro-inflammatory or inflammasome- associated cytokines comprise at least one of IL-1α, IL-1β, IL-2, IL-5, IL-6, IL-8, IL-12, IL-15, IL-17, IL-18, IP-10, MCP-1, TNFα, HIF-1α, COX-2 and VEGF, optionally wherein the pro- inflammatory or inflammasome-associated cytokines comprise at least one of IL-1, IL-1α, IL- 1β, IL-6, or IL-18, or any combination thereof. 34. The composition for use of any one of embodiments 31 to 33, wherein the subject has elevated vaginal levels of Th1 cytokines. 35. The composition for use of embodiment 33, wherein the Th1 cytokines comprise at least one of IFNγ, IL-12, STAMBP or TNF. 36. The composition for use of any one of the preceding embodiments, wherein the subject is further characterized by reduced vaginal levels of IGF-1, IL-4, IL-10, TGFβ and/or CCL5. 101  \\4163‐8733‐4730  v3                37. The composition for use of any one of embodiments 33 to 36, wherein after administration of the composition to the subject one or more of: the elevated vaginal levels of pro-inflammatory or inflammasome-associated cytokines in the subject are reduced; the elevated vaginal levels of Th1 cytokines in the subject are reduced; and/or the reduced vaginal levels of IGF-1, IL-4, IL-10, TGFβ and/or CCL5 in the subject are increased. 38. The composition for use of any one of the preceding embodiments, wherein the substantially complete vaginal microbiota preparation further comprises vaginal transudate and/or mucus, optionally wherein the mucus is cervicovaginal mucus. 39. The composition for use of any one of the preceding embodiments, wherein the substantially complete vaginal microbiota preparation was obtained from a donor subject and further wherein the substantially complete vaginal microbiota preparation comprises substantially all detectable bacterial, viral, fungal species, and/or metabolites, that are present in the genitourinary tract, e.g. the vagina, cervix and/or uterus, of the donor subject. 40. The composition for use of any one of embodiments 1 to 39, wherein the composition further comprises a pharmaceutically acceptable carrier or diluent, optionally wherein the diluent is saline. 41. The composition for use of any one of embodiments 1 to 40, wherein the method further comprises transferring of a human embryo to the subject. 42. The composition for use of embodiment 41, wherein the human embryo has not previously been frozen. 42. The composition for use of embodiment 41, wherein the human embryo has previously been frozen. 44. The composition for use of any one of embodiments 41-43, wherein the human embryo is transferred after 1 week, 2 weeks, 3 weeks, or up to 12 weeks after administering the composition. 45. The composition for use of any one of embodiments 41-44, wherein the method further comprises one or more of (a) determining a partial or complete reversal of the subject´s dysbiotic vaginal microbiota after administration of the composition such that the subject’s vaginal microbiota comprises (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; 102  \\4163‐8733‐4730  v3                and (ii) less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; (b) determining a reduction of pro-inflammatory or inflammasome-associated cytokines (e.g., IL-1, IL-1α, IL-1β, IL-6, or IL-18); and/or (c)determining a reduction of Th1 cytokines (e.g., IFNγ, IL-12, STAMBP or TNF). 46. The composition for use of any one of embodiments 1 to 41, wherein a single dose or multiple doses of the composition are administered to the subject. 47. The composition for use of embodiment 46, wherein multiple doses of the composition are administered to the subject over consecutive days. 48. The composition for use of embodiment 46 or 47, wherein three doses of the composition are administered to the subject, wherein one dose is administered to the subject on each of three consecutive days. 49. The composition for use of embodiment 46 or 47, wherein 1-3 doses of the composition are administered to the subject on each of three consecutive days. 50. The composition for use of any one of embodiments 44-49, wherein a dose of the composition is at least 1x10 4 colony forming units (CFUs). 51. The composition for use of any one of embodiments 44-49, wherein a dose of the composition is 1x10 3 to 1x10 12 colony forming units (CFUs). 52. The composition for use of any one of the preceding embodiments, wherein the composition is administered repeatedly until the subject´s dysbiotic vaginal microbiota is lactobacillus- dominant, e.g., comprises at least 60%, 70%, 80%, 90% or 95% lactobacillus species, wherein the species are selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, and/or Lactobacillus gasseri. 53. The composition for use of any one of the preceding embodiments, the Lactobacilli comprised in the substantially complete vaginal microbiota preparation are capable of stably engrafting (e.g., colonizing) the subject´s vaginal or uterine cavity for a time period of at least 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 18 months, 24 months or longer. 54. The composition for use of any one of the preceding embodiments, wherein about 80-99.9% of all detectable bacterial species of the preparation consist of Lactobacillus crispatus. 55. The composition for use of any one of the preceding embodiments, wherein about 80-99.9% of all detectable bacterial species of the preparation consist of 103  \\4163‐8733‐4730  v3                a) Lactobacillus crispatus; b) Lactobacillus iners; c) Lactobacillus crispatus and Lactobacillus iners; d) Lactobacillus crispatus and Lactobacillus jensenii; e) Lactobacillus crispatus, Lactobacillus iners and Lactobacillus jensenii; f) Lactobacillus crispatus, Lactobacillus gasseri and Lactobacillus jensenii; g) Lactobacillus iners and Lactobacillus jensenii; h) Lactobacillus iners, Lactobacillus jensenii, and Lactobacillus gasseri; i) Lactobacillus iners and Lactobacillus gasseri; or j) Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, and Lactobacillus gasseri. 56. The composition for use of embodiment 53, wherein for (c) to (j) Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri may be present in greater relative quantity than one or more of the other vaginal lactobacilli present in the preparation. 57. The composition for use of any one of the preceding embodiments, wherein less than 10% of all detectable bacterial species of the dysbiotic vaginal microbiota in the genitourinary tract of the female subject belong to the genus Lactobacillus, and at least 20%, 30%, 40%, 50%, 60%, 70% or more of all detectable bacterial species of the dysbiotic vaginal microbiota are pathogens or pathobionts comprising Gardnerella spp., Atopobium spp., and/or Prevotella spp.. 58. The composition for use of any one of the preceding embodiments, wherein the composition is in the form of a suspension, spray, gel, cream, ointment, semi-solid foam, film, powder, capsule, solution for lavages or douches, ovules, a vaginal insert, tampon, tablets or a microencapsulated product. 59. The composition for use of any one of the preceding embodiments, said composition comprising at least about 10 6 viable bacterial cells, preferably at least about 10 7 viable bacterial cells. 60. The composition for use of any one of the preceding embodiments, said composition further comprising further lactobacilli other than Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, or Lactobacillus gasseri, wherein the further lactobacilli are present in a concentration of about 0.01 – 1% of all detectable bacterial species of the preparation, optionally wherein the further lactobacilli are Atopobium spp., Bifidobacterium vaginale, Fannyhessea vaginae, and/or Prevotella spp. 104  \\4163‐8733‐4730  v3                61. The composition for use any one of the preceding embodiments, wherein the substantially complete vaginal microbiota preparation is obtained by a culture-independent method. 62. A method of producing a substantially complete vaginal microbiota preparation, said method comprising (a) processing a microbiota sample from a donor female genitourinary tract , e.g. a vaginal mucosal sample or cervicovaginal secretion, comprising urogenital microbes and vaginal mucosal fluid from the vaginal cavity of a healthy donor subject in a centralized processing facility, (b) assessing the absence of one or more pathogens, (c) assessing viability and/or quantity of the urogenital microbes, and (d) releasing the composition comprising the processed vaginal mucosal sample from quarantine for use in an assisted reproductive procedure, if a predetermined level is obtained in step (b) and (c). 63. The method of embodiment 62, wherein the method of obtaining the preparation further comprises one, two, three, four or all of (a) adding at least one pharmaceutically acceptable diluent, excipient or carrier; (b) adjusting the pH, osmolarity and/or viscosity of the vaginal mucosal fluid; (c) adding one or more cryoprotectants (e.g., for freezing) and/or one or more lyoprotectants (e.g., for drying); (d) formulating the processed mucosal fluid into a dosage form comprising a powder, a solid, a semi-solid, or a liquid: (e) partitioning the vaginal mucosal fluid into discrete units, each unit comprising an effective dose of urogenital microbes, wherein the effective dose of urogenital microbes comprises at least 10 5 colony forming units (CFU), preferably at least 10 6 colony forming units (CFU), more preferably at least 10 7 colony forming units (CFU); (f) storing the refrigerated, frozen or dried vaginal mucosal fluid sample or processed preparation under quarantine; (g) holding the refrigerated, frozen or dried vaginal mucosal fluid sample or processed preparation under quarantine until any completion of any combination of (a) testing the donor to exclude the substantial presence of one or more transmissible pathogens, (b) confirming the composition and viability of the urogenital microbes comprised, or (c) further confirming the health of the donor by a plurality of post-screening tests; (h) standardizing the cell count and/or the quantity or concentration of the urogenital microbes comprised in the preparation, optionally by adding an inert filler; and (i) releasing the refrigerated, frozen or dried mucosal fluid sample or processed preparation from quarantine to define the substantially complete vaginal microbial preparation. 64. The method of embodiment 63, wherein the preparation comprises (i) one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, 105  \\4163‐8733‐4730  v3                Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise >80-99.9% of all detectable bacterial species of the preparation; and (ii) Less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp. EXAMPLES Example 1: Screening of women to identify donors and recipients This Example describes the process of identifying suitable donors based on the analysis of the vaginal microbiome composition and absence of pathogens. A schematic overview of the screening is shown in Figure 1. Participant enrollment and vaginal samples Healthy women without a history of vaginal health issues were recruited. Enrolling participants were informed, consented and provided a vaginal swab for microbiome analysis, and a separate swab for HPV analysis. A total of 96 women consented and provided samples. For the last 60 women screened, instead of a vaginal swab, a cervicovaginal secretion (CVS) sample was obtained using a vaginal self-sampling device (e.g., a pliable menstrual cup that is inserted into the vaginal cavity, such as a Softdisc menstrual cup by The Flex Company, also sold under the name ‘Flex disc’) to enable both microbiome and biomarker analysis, as well as a dedicated swab for HPV screening. Both sample types were obtained via self-sampling by donors after thorough instruction of the donor on the correct sampling procedure. Microbiome analysis The microbiome composition from the vaginal swab or CVS samples was determined by shotgun DNA sequencing analysis. Swabs for vaginal microbiome analysis were kept at 4°C for up to 48 hours prior to DNA extraction. CVS samples were diluted with saline to reduce the viscosity, aliquoted (for procedure, see Example 3) and stored at -80°C prior to DNA extraction. DNA was extracted from both sample types using the Molysis Complete5 kit (MolZym), which uses a differential lysis method to extract microbial DNA and remove human DNA. Shotgun sequencing and bioinformatics analyses of microbiomes was performed by Seqbiome (Cork, IE). All samples were prepared for shotgun metagenomic sequencing according to Illumina Nextera XT library preparation kit guidelines, with the use of unique dual indexes for multiplexing with the Nextera XT index kit (Illumina). Samples were sequenced on an Illumina NextSeq 500 sequencing platform with a v2.5 kit (a 300-cycle kit/150bp PE sequencing), at the Teagasc DNA 106  \\4163‐8733‐4730  v3                Sequencing Facility, using standard Illumina sequencing protocols. Quality of the raw sequencing data was assessed using FastQC. Samples that did not meet minimum quality check cutoff or a sequencing depth of at least 4M reads underwent re-sequencing. Shotgun metagenomic sequencing data were then processed through analysis workflow that utilizes Kneaddata wrapper tool. Quality filtering and host genome decontamination (human) were performed utilizing Trimmomatic and Bowtie2. Taxonomic classification of quality filtered reads was further performed using Kraken2 species classifier using a customized version of Genome Taxonomy Database (GTDB) that also includes reference sequences belonging to archaea, fungi and viral genomes. Kraken2 classifications were then passed to Bracken tool to estimate species level abundance. The vaginal microbiome composition was determined for each putative donor and recipient by obtaining information regarding the presence and relative abundance of bacterial species. For this study, to qualify as a donor, the vaginal microbiome composition had to pass two criteria: to comprise at least 80% vaginal lactobacilli (L. crispatus, L. iners, L. jensenii, L. gasseri) and to comprise less than 5% selected pathogens (Atopobium spp., Prevotella spp., B. vaginale, and F. vaginae). The vaginal microbiome composition of 61 out of 96 women (64%) satisfied these two criteria and were considered healthy vaginal microbiomes. The relative abundance of the lactobacilli present in the vaginal microbiota are depicted in Figure 3, wherein each bar represents the microbiome composition of a single healthy donor. The relative quantities of species are indicated in the y-axis. The microbiomes of the screened donors differed in their relative composition. In several instances, the microbiome was dominated by a single species, e.g., L. crispatus, wherein other microbiomes showed a heterogenous population of lactobacilli, e.g., comprising a combination of L. crispatus, L. iners and L. jensenii. Of note, even minute relative quantities, such as less than 0.05% could be detected (see, Table 2). Of the 96 women screened, 28% (n=27) exhibited a dysbiotic microbiome (defined as >20% selected pathogens and <10% vaginal lactobacilli) (see, Figures 2 and 4). The women that exhibited dysbiotic vaginal microbiota were free of vaginal disease symptoms and of general good health. The remaining 8% (n=8) fell between the healthy and dysbiotic microbiome classifications, did not exhibit any vaginal disease symptoms, or contained species not classified/defined in the screening criteria (Figure 4). These women did not qualify as putative donors or recipients. 107  \\4163‐8733‐4730  v3                The microbiome compositions of the healthy cohort (n=61) had a median vaginal lactobacilli abundance of 99.26% and selected pathogens of 0.03%. In contrast, the dysbiotic cohort (n=27) was characterized by a median vaginal lactobacilli abundance of 0.34% and selected pathogens of 87.21%. The undefined cohort (n=8) was characterized by a median vaginal Lactobacilli abundance of 35.76% and selected pathogens of 61.83%. This suggests that the selection criteria (see, Figure 2) can reliably distinguish healthy and dysbiotic vaginal microbiota with high certainty. Only healthy vaginal microbiomes were considered as putative donors and underwent further stringent screening procedures. HPV screening Human papillomavirus (HPV) is a highly prevalent viral infection, several strains of which are associated with cervical cancer. The prevalence of HPV-positive women is high. On the vaginal swabs taken for HPV screening during the donor’s screening visit, DNA extraction was performed using the Qiagen QIAmp DNA mini kit. Extracted DNA from each donor sample was used in the SeeGene Anyplex II HPV28 kit and ran semi-quantitatively on the BioRad CFX96 Dx qPCR machine, which was set up and calibrated for this assay (Triolab, DK). The semi-quantitative method provides three levels of quantity for 28 different genotypes of HPV, which included all known high-risk genotypes. Only samples that were HPV-negative were considered suitable putative donors. Pathogen check and examination by medical staff To minimize any adverse effects for the recipients, putative donors (women who had a healthy microbiome and passed the HPV screen) were further screened by a gynecologist for the presence of pathogens, pathobionts, and sexually transmitted diseases, and underwent a medical and gynecological examination to assess the presence of other diseases such as cancer or endometriosis. The procedure included an additional HPV test. Standard diagnostic tests were performed for HIV, Hepatitis A, B, and C, cytomegalovirus, Treponema, urinary tract infections, HPV, chlamydia, gonorrhea, Trichomonas, Herpes genitalis, Candida, Mycoplasma, and Streptococcus A, B, C, and G. During the medical examination, putative donors were subjected to a general health check including medical history and medication usage, demographics, heart rate and blood pressure measurements. 108  \\4163‐8733‐4730  v3                For approved donors, the same tests were again performed at a follow-up visit after they had provided their last donations over a specified time period (see, Figure 1). Until approved donors passed the test at the follow-up visit, and all samples passed all quality checks (see, Example 4), the samples remained quarantined and not released for administration to a recipient. Donor selection Donors were selected on the screening procedure described above, including microbiome analysis, pathogen screening, and medical and gynecological examination. Only subjects that had a healthy vaginal microbiome, had no positive pathogen test, and had no abnormal findings in the medical and gynecological exam were considered suitable donors and were enrolled in the program (see also, Example 2). Following the screening protocol, 12 (13%) out of 96 screened women were enrolled into the donor program and started their donation visits. Of these, three failed to provide sufficient donations or failed during follow-up screening. Overall, of all 96 women who enrolled for screening 9% fully passed all screening criteria resulting in nine approved donors (n=9) (Table 1). Table 1 provides an overview of the pathogens and pathobionts that were screened for in donor subjects (n=38) that had passed HPV screening. n positive Screening 109  \\4163‐8733‐4730  v3                Mycoplasma 1 Strep A/B/C/G 4 p g y approved donors (n=9) is summarized in Table 2. Table 2 Vaginal microbiota compositions of four cohorts: (i) Healthy, (ii) fully approved donors, (iii) dysbiotic and (iv) undefined. Shown are the relative amounts of the quantified bacteria in median and interquartile range (IQR) (in %) relative to the total amount of detectable species in the sample preparation. Healthy Fully approved Dysbiotic Undefined 9 5 5 1 110  \\4163‐8733‐4730  v3                Total selected 0.03 0.50 0.01 0.08 87.21 10.10 61.83 49.59 pathogens 0 “Healthy”, “Dysbiotic” and “Undefined” cohorts were categorized based on the relative quantities of the vaginal lactobacilli and pathogens as described above (see also, Figure 2). “Fully approved donors” refers to subjects that, in addition to passing the first screen successfully underwent additional screens, e.g., to exclude STIs and other infections and medical conditions as described above. Subjects that passed all screening criteria and qualified as suitable donors (n=9) had a median vaginal lactobacilli concentration of 99.62% and selected pathogens of 0.01%. Approved donors had the highest amount of selected vaginal lactobacilli and the lowest amount of vaginal pathogens of the groups. Fully approved donors were not limited to L. crispatus-dominant vaginal microbiota compositions but comprised a mixture of lactobacilli species or were L. iners dominant. Recipient selection Recipients were recruited and enrolled in clinical studies. In one study, healthy volunteer women aged 18 to 45 were recruited for screening and participation. Only women without vaginal disease symptoms and of general good health were enrolled for screening. Another study enrolled a single patient with vaginal symptoms. All recipients were classified as having vaginal dysbiosis (harboring a dysbiotic vaginal microbiome) according to the inclusion criteria defined above (see, Figure 2): >20% selected pathogens (Atopobium spp., Prevotella spp., B. vaginale, and F. vaginae) and <10% vaginal Lactobacilli. Example 2: Obtaining donor CVS samples This Example describes the process of obtaining vaginal microbiota samples from a donor, wherein the sample comprises substantially complete vaginal microbiota. Donation visit setup Donors that successfully passed the screening process described in Example 1 were invited to donate cervicovaginal secretions (CVS) within a time period of 40 days between the 111  \\4163‐8733‐4730  v3                two gynecologist/pathogen check visits (see, Figure 1). Each donor provided 10-15 donations at any time during the 40 days except on days during menstruation and one day thereafter. The donations were spaced at least 16 hours apart. During the donation period, donors needed to adhere to the following restrictions: abstinence from vaginal and anal sexual intercourse; no swimming in lakes, Jacuzzis and swimming pools; no use of intravaginal products (e.g., tampons, soap). At each visit, the donor filled out a questionnaire to affirm adherence to these restrictions together with general health questions. After the donation period, the donors underwent a follow-up check at the gynecologist. Only if they passed this follow-up, were their samples considered for release and use for administration (see, Figure 1, Example 1). Until that time, and until all samples passed all quality checks (see, Example 4), all samples were kept in quarantine. Donor self-collection of CVS Cervicovaginal secretion (CVS) samples were obtained through self-collection using a vaginal self-sampling device after thorough instructions. Donors obtained CVS samples in a dedicated, hygienically designed donor room. The donor room was cleaned with 70% ethanol after each donor and subjected to biweekly environmental monitoring to check for Enterobacteriaceae, total aerobic microbial count, and yeast and mold. This setup maximizes cleanliness and minimizes minimized processing time, compared to, e.g., home sampling. Only a single contamination was detected in one of the donor samples consisting of skin bacteria, caused by the donor not following the sampling procedure correctly. The vaginal self-sampling device was a single use menstrual cup with a flexible/pliable ring and plastic foil cup (described in Example 1). For CVS donations, it was not worn like a menstrual cup over the cervix, but instead used as a large swab by inserting it partially folded into the vagina, leaving it in a longitudinal position for about 10 seconds and twisting it along its longitudinal axis while removing it. The donor deposited the vaginal self-sampling device into a provided labeled and pre-weighed sterile 50 mL tube. After 15-20 min, this process was repeated a second time with a new vaginal self-sampling device, which was placed in a separate sterile 50 mL tube. The soft and pliable material of the vaginal self-sampling device in conjunction with it being inserted partially folded into the vaginal canal enables the effective collection of CVS from 112  \\4163‐8733‐4730  v3                the surface of the vaginal cavity, without damaging or irritating the vagina. The vaginal self- sampling devices are intended and safe for vaginal use, but to ensure maximum donor safety and control, each batch of the devices was screened for contamination of Enterobacteriaceae and confirmed to be free of any contamination. The procedure described here is believed to have several advantages over using the vaginal self-sampling device over a prolonged time period as a collecting device over the cervix. With the above method, the bacteria comprised in the CVS sample will spend less time in contact with the vaginal self-sampling device, and the amount of vaginal mucus and vaginal bacteria that is collected is increased. The vaginal epithelium contains the substrates for the vaginal microbiome. Thus, a sample obtained in this manner has a higher concentration of viable vaginal lactobacilli and mucus, and a lower amount of fluid from the endometrium. Example 3: Producing a SCVMP This Example demonstrates the production of a SCVMP from cervicovaginal secretions. Process to produce a SCVMP A schematic representation of the sample processing is provided in Figure 5. At each visit, the donor was provided with two 50 mL sterile tubes, which were pre-labelled and pre- weighed, and two vaginal self-sampling devices, along with the questionnaire (see, Examples 1 and 2). The CVS was collected by centrifuging for 5 min at 190 x g and ambient temperature. The low speed collects the CVS from the device, while not phase-separating into layers. All further steps were conducted under sterile conditions at ambient temperature. The self-sampling devices were discarded from the tubes and the CVS sample weight was determined. Samples with a total (two tubes combined) weight of less than 200 mg were discarded. Samples in which blood was visibly present were discarded. The sample in each tube was mixed with 1 mL saline to reduce viscosity, after which the two samples were combined and aliquoted for storage and further testing. The two combined samples were then distributed over several aliquots for quality control (see, Example 4) and storage as shown in Figure 5. The cryovials containing samples for storage were placed in a CoolCell (Corning) and then at -80°C. A CoolCell has a controlled cooling rate of 1°C per minute, which ensures maintaining maximum viability of the samples. After a minimum of 2 hours, the samples were 113  \\4163‐8733‐4730  v3                transferred into a regular -80°C storage box labelled ‘quarantined’. Samples were released only after all release criteria had been met (see, Figure 5 and as described above). Example 4: Quality control This Example describes the quality control of a SCVMP produced from cervicovaginal secretions, so it can be used safely for administration. Overall procedure A schematic representation of the sample processing procedure with details about quality control is provided in Figure 5. This procedure is highly optimized, in such a way that the volumes used for analyses and quality control are as low as possible to minimize loss of SCVMP. The sample used for pH measurement is discarded after measurement. The retention vial is maintained for at least 1 year after administration for safety reasons (e.g., to check for STIs in case one occurred in a recipient). Every first and last sample of each donor was subjected to a qPCR analysis to check for the absence of multi-drug resistance genes (MDR genes). Analyses for quality control The pH was measured using a micro-pH probe. Technical triplicate measurements were performed, and repeated if the difference between measurements was > 0.2. The sample used for pH measurement is discarded after measuring. Microscopy was performed. The absence of sperm cells was determined optically by microscopy and using acid phosphate paper, a highly sensitive and selective method to identify sperm cells. Viability was tested by colony-forming units (CFU) count on de Man, Rogosa and Sharpe (MRS) agar plates or with viable cell count (VCC) for donors who at screening were dominant in L. crispatus, L. jensenii, or L. gasseri. For donors who at screening were dominant for L. iners, this method could not be used. Instead, viability for these samples was tested using BacLight live/dead staining (ThermoFisher Scientific) and counting the viable cells/mL in a Thoma cell counting chamber under the microscope. Within one week after a sample was used for administration, a stability vial was used to test cell viability at the time of vaginal administration, and dose calculation. DNA extraction was performed using the Molysis Complete5 kit (Molzym) according to the manufacturer’s instructions to obtain sufficient bacterial sequence reads to perform in silico engraftment check after administration based on metagenome data (see, Example 1 for methods used). The multi-drug resistance (MDR) marker qPCR was performed using the same DNA as 114  \\4163‐8733‐4730  v3                was used for Shotgun sequencing, using the SeeGene Allplex Entero-DR qPCR assay kit on a BioRad CFX96 Dx qPCR machine calibrated for the assay. This kit allows single or multiple detection of carbapenemase genes (NDM, KPC, OXA-48, VIM, IMP), extended spectrum beta- lactamase (ESBL) genes (CTX-M), and vancomycin resistance genes (VanA, VanB). Example 5: Donor microbiome characterization This Example describes the SCVMPs suitable for vaginal administration. Microbiome compositions during the donation period It is known that the vaginal microbiome in women can fluctuate over the menstrual cycle or depending on sexual activity (Gajer et al., 2012, Science Translational Medicine). For donors with mixed species compositions that did not use contraception (Table 3), fluctuations between the species were observed over the menstrual cycle (Figure 6 A, B), but the totality of L. crispatus, L. iners, L. jensenii, L. gasseri in the sample remained stably >80%. The microbiome of donors with a strongly L. crispatus-dominant microbiome was very stable over extended periods of time (e.g., Donor 7, Figure 6 G). The microbiome of L. iners-dominant donors was mostly stable, although in one case a shift between L. iners and L. crispatus was observed towards the end of the donation period (Figure 6I). This donor did not have a menstrual cycle due to due contraception. The microbiome stability observed in the donors is likely aided by the restrictions that the donors adhere to, such as, e.g., no sexual intercourse. Some donors returned for a second round of donation visits. In Figure 6, this is indicated by a vertical line. There was a 1 month in-between two rounds for donors 2, 5, and 7, and a 1,5- months for donor 1. For donor 6, there was a 2-months in-between the rounds, and she changed from using contraceptive pills in the first round to no hormonal contraceptives in the second round. In several donor samples, a certain species (mostly L. jensenii) was present in small but very consistent amounts (0.3-3.5%). In one of these donors, an even smaller amount of L. iners was consistently present (0.07-0.33%). Even smaller amounts of both L. iners (0.02-0.10%) and L. jensenii (0.01-0.03%) were consistently observed in yet another L. crispatus-dominant donor. In the two donors with mixed species composition, none of the species present in the mixture fully disappeared (below detection level) over the donation period even though their relative 115  \\4163‐8733‐4730  v3                abundances sometimes decreased to as low as 0.27%. Altogether, this implies that the vaginal microbiome is a stable ecosystem and points to a symbiotic relationship between the different Lactobacillus species in one person. This is further substantiated by the observations of the vaginal administration of the preparations, as described in Example 6. In addition to the four main vaginal lactobacilli (L. crispatus, L. iners, L. jensenii, L. gasseri), other lactobacilli were regularly observed to be consistently present in small amounts in donor samples (mostly <0.05%): L. acetotolerans, L. acidophilus, L. amylovorus, L. gallinarum, L. gigeriorum, L. helveticus, L. johnsonii, L. kefiranofaciens, L. kitasatonis, L. paragasseri, L. psittaci, Lactobacillus sp002911475, L. taiwanensis, L. ultunensis, L. coleohominis, L. reuteri, and L. vaginalis. The stable presence of these lactobacilli further points to a complex ecosystem that in its entirety might be needed to promote and maintain a healthy vaginal niche. Some other lactobacilli appeared sporadically in a subset of the donor samples. L. helveticus was not observed in the two L. iners-dominant donors, and only appeared in the last visit of a single donor who shifted from L. iners-dominant to L. crispatus-dominant, which may suggest that certain species prefer cohabitation with each other while others might be incompatible in the ecosystem. In contrast to reports in the literature where L. iners-dominant donors were not considered suitable for administration, the data suggest that L. iners-dominant microbiomes of fully approved donors have a very stable and healthy ecosystem (see also inflammatory marker data in Example 7) and are suitable donors for SCVMPs. L. gasseri was infrequently observed as a dominant species (Figure 3) but was typically found in small amounts in several of the donors (Figure 6, Table 1). L. gasseri was detected in L. crispatus-dominant donor 4 (Figure 6 D) in relative concentrations of 0.01- 2.23%; in mixed microbiome donor 1 (Figure 6 A) in relative concentrations of 0.01-0.07%; and in L. iners- dominant donor 8 (Figure 6 H) in relative concentrations of 0.3-7.14%. The consistent maintenance of minor Lactobacillus species suggests that the minor species might play a hitherto unknown role in maintenance or stability of the vaginal ecosystem. Physical properties of the obtained samples The weight of samples fluctuated among donations of the same donor and among donors, but on average was >200 mg. CFU and pH remained stable and within the defined threshold of <4.5 (Table 3). Altogether, this stability over both the microbiome composition and sample properties indicates the health and stability of the donor microbiomes. 116  \\4163‐8733‐4730  v3                Table 3 summarizes the properties of the CVS and SCVMPs that are generated. Each row contains data for one donor during their 10-15 donations over a 40-day period. The ‘Time window’ column lists the number of days during which the donor provided the number of samples listed in the ‘Nr of donations’ column. Donor ID is the same as in the microbiome graphs in Figure 6. The weight is the combined weight of the two samples provided by the donor, prior to adding saline. The dose is the final amount of mL in the substantially complete microbiome preparation vial used for dosing a recipient, after all volumes for analyses have been taken out (see, Figure 5). The maximum dose is 1,8 mL to fit in a cryovial. Viable cells/dose was determined by CFU plate counting on MRS medium grown anaerobically for 2-3 days for all species except for the two L. iners-dominant donors (8 and 9). For these, viable cells/dose was determined by live/dead staining and counting viable cells in a counting chamber under the microscope. Abbreviations: hIUD: hormonal intrauterine device; pill: oral contraceptive. 117  \\4163‐8733‐4730  v3    s e g a r e v A ) x a m - n i m ( s e g n a R w e o ) s m i d n T i y a w d ( 8 2 6 3 5 2 1 3 0 3 0 2 6 1 1 3 4 2 7 2 s n f oi o t o a n N o d 5 1 0 1 1 1 4 1 2 1 4 1 3 1 2 1 4 1 3 1 - a r t n o n i o t p e n e n e n D D D U l l l U U C e c o n o n o n I l h i l p i l p i p I h I h r ) e e + i h t s ( r e o s d r + + + . d r . a m o s i u s s u s a s u i s i s i l L a w L w o t b t a t g t i o r d c i e d x i e p a s x i p . a p n u e t a i u t l p n e a p i c + a ( s o t + i ( s s u t 3v i r s i L c r c e s i m r s c n 0 e s i j r s c n e s i j r b c o r t e r r n i e s s ) e d n a i p si ) d 3 3 7 4‐ 3 M M M . L . L o s . L . L . L . L . L c a l . L a g n e . L r c n e e l 3 b 7 a 8‐ 3 6 T 1 4 \ r e g \ o n a r o e D D I 1 2 3 4 5 6 7 8 9 v A   It was further evaluated whether repeated CVS donations would affect the composition of the sample. Donors provided two samples 2x per day with a 6-hour interval and 3x per day with a 4-hour interval. Both of the repeated CVS donation procedures resulted in a significant increase of the pH (approx.0.4 increase), and a decrease of sample weight (to around or below 200 mg) and CFU (1 log), rendering repeated sampling within a single day unsuitable. This suggests that the microbiome requires more than 6 hours to fully regenerate after sampling. Consequently, donors were allowed to give samples once a day at most with approximately 16- hour intervals between donations. Example 6: Treating dysbiotic microbiomes through vaginal administration of the to revert a recipient’s dysbiotic microbiome to a donor’s healthy microbiome using vaginal administration, thereby treating the dysbiotic microbiome. Administration of SCVMP and results The SCVMP sample was first thawed by moving it from -80°C to room temperature for 40 minutes. Thereafter, the sample was placed in an incubator at 37°C for 30 minutes. The tube containing the sample was then gently inverted 5 times for mixing. The sample was drawn up into a 5 mL syringe and applied intravaginally to the recipient lying in the lithotomy position using an insemination catheter attached to the 5 mL syringe. The recipient was instructed to remain lying down in a horizontal position for 30 minutes following the sample being inserted intravaginally. 21 recipient subjects were treated with the SCVMP obtained from healthy donors as described above. Two representative changes of a dysbiotic vaginal microbiota after administration of a SCVMP are shown in Figure 7 and discussed in detail in the following. Both recipients received 3 doses (1 dose/ day over the course of 3 consecutive days) (Figure 7A and 7B). The recipients were not pre-treated with antibiotics prior to or during the administration of the preparation. After administration of the preparation, the microbiome changes of the recipients demonstrate that the SCVMP is capable of changing a dysbiotic microbiome to a microbiome more closely resembling that of the donor, by administration of the SCVMP alone (i.e, without treatment with antibiotics).

119  \\4163‐8733‐4730  v3      All recipients were enrolled based on their microbiome at screening, which was generally one month before their visit. At their visit for administration of the SCVMP, their microbiome was checked again as baseline measurement. Both recipients were vaginally asymptomatic. Recipient 1 was vaginally asymptomatic, while recipient 2 showed vaginal disease symptoms at the time of administration. Recipient 2 reported a marked decrease in symptoms 1 week after administration of the preparation, and full disappearance of all vaginal disease symptoms after 2 weeks. The post-administration microbiome of the recipients appeared similar to the donors’, in what could be termed ‘microbiome twinning’. The dysbiotic vaginal microbiomes of recipients 1 and 2 were thus successfully reversed to a healthy, non-dysbiotic microbiome, and remained stable over a period of at least 5 or 3 months, respectively (Figures 7A and 7B). Overall, the post-administration recipients clustered together in an unsupervised principal component analysis (PCA) plot with the donor samples, while the pre-administration recipients form a separate cluster (Figure 8A-8C). This suggests that the vaginal microbiome of the recipient after administration of the preparation did not only change from a dysbiotic state but resembles the vaginal microbiome composition of the healthy, non-dysbiotic donor. As a blinded approach, to check engraftment by the specific donor microbiome in one of the recipients vaginal niche, the post-treatment recipient microbiome was compared to a library of all donor microbiomes (metagenomic sequencing data). It was possible to identify correct donor sample from the donor library based on the closeness to the recipient microbiome, suggesting that engraftment of the donor microbiome in the recipient was successful. The microbiome compositions of the recipients pre- and post-administration of the SCVMP(s), and the composition of the respective donor are summarized in Table 5. The Table shows the relative abundances (determined by Shotgun sequencing) of species in donor and recipient samples, wherein after administration of the preparation ‘microbiome twining’ was observed in each case, i.e., donor species cultivated in the vaginal niche of recipients including species that were present in the donor microbiome in low quantities, and were absent in the recipient prior to administration of the preparation. The relevant species where this phenomenon is observed are highlighted in the grey columns. The post-administration microbiome of the recipient included species that were present in minor quantities in the donor microbiome (Table 5; wherein L. is Lactobacillus and B. is

120  \\4163‐8733‐4730  v3      Bifidobacterium), suggesting that the entire stable ecosystem was transferred from the donor to the recipient. It was also observed that these species were stably present for all donation visits of most donors (see, Example 5). The transfer of the entire ecosystem to the recipient through administration of a SCVMP may allow for successful engraftment and colonization of the lactobacillus-dominated donor microbiome, even in the absence of an antibiotic pre-treatment used to eradicate residing pathogens and pathobionts and create a substantially empty microbial niche. This might explain why single species or single strain preparations that have previously been tested generally do not work well. Alternatively or in addition, there might be a need for certain substances in the SCVMP (e.g., mucin, lactic acid, etc.) to support initial engraftment. Two different donors were used in recipient 1 and recipient 2, with three multiple visits for each. For each recipient, across those three samples, the species are the same but their relative abundance is different, indicating that the abundance of a species is not necessarily the determining factor. Engraftment appears successful when the entire ecosystem is present in the donor material, thus requiring a substantially complete preparation. Other researchers have previously suggested a harmful role of L. iners. However, L. iners is present in the donor microbiomes that were tested. In women that pass the stringent screening criteria described herein, L. iners may also play a be beneficial role in representing healthy, stable microbiomes. This confirms the selection process to use all four main Lactobacillus species for administration of the preparation. This Example thus demonstrates the successful treatment of a dysbiotic vaginal microbiome by administration of a SCVMP to a dysbiotic recipient, wherein post-administration the recipient´s microbiota composition closely resembled the donor´s microbiota composition. While antibiotic treatment prior to administration was thought to be required -as proposed by others- these data demonstrate that pretreatment with antibiotics is not required if SCVMPs are provided that contain a substantially complete ecosystem.

121  \\4163‐8733‐4730  v3    h t 0 0 . 0 0 0 . 0 0 0 . 5 0 6 . 2 5 0 . 5 0 0 . 2 a 0 0 . 1 0 0 . p 0 l a n a b 4 0 . 4 0 0 o t 0 0 . 0 0 . 0 0 . 3 0 0 . 4 0 0 . 3 0 0 . 3 0 0 . 0 c a L l a 4 n i 4 . 1 0 4 . 0 0 0 . 0 0 0 . 9 0 3 . 6 2 7 0 4 . 0 5 . 0 6 . 0 g a v . f s o t 0 0 . 0 0 0 . 1 0 0 . 1 0 0 . 0 0 0 . 0 0 0 . 0 0 0 . 0 0 0 . ) n e 0 i % ( p i c 0 0 3 e c e r 0 . 0 0 . 0 0 . 0 0 0 . 0 0 0 . 0 0 0 . 1 0 0 . 0 0 0 . 0 n a y d r n a l 0 . 0 6 9 u p 0 5 5 0 6 0 0 . 0 0 . 0 0 . 4 2 . 0 2 . 0 1 . 0 5 . 1 b a m e e x 1 . 9 2 . 0 0 0 7 3 5 2 2 v i e 8 5 4 9 2 9 9 9 . 0 0 . 0 . 5 . . . 9 5 9 6 9 4 9 t o a l w t r o r n o g o n D o n i g n n i k e h t s h s e h R n i 3v 0 e s o e w n o t n t o n o . 2 D 5 P 3 7 4 e 3 e r s e c d 1 m S f o 1 m 2 m 3 3 e o s l M 3 7 D o y D a D b a V 8‐ 3 6 T C S 1 4 \ \   Example 7: Elevated vaginal inflammatory markers in dysbiotic women This Example demonstrates that dysbiotic vaginal microbiomes represent a local inflammatory state which is distinct from healthy women. Biobanking of screening cohort CVS for biomarker analysis CVS samples were collected as described for the SCVMP (see Example 2) but with the following differences: Samples were immediately placed on ice when received and kept cold throughout the entire processing procedure. Cold instead of room temperature sterile saline was used, and samples were frozen to -80°C without the use of a CoolCell. Instead of adding 1 mL sterile saline per sample, 2,5 µL was added per mg sample so all samples were normalized for weight prior to analysis. The quality checks were omitted (CFU, pH, sperm cell check), except sequencing. Inflammatory protein analysis Bacterial vaginosis (BV)-associated and dysbiotic vaginal microbiota have been linked to increased concentrations of several proinflammatory cytokines such as IL-1a, IL-1b, IL-8, IL-12, IL-18, and FMS-related tyrosine kinase 3 ligand (FLT-3L), as well as matrix metalloproteinases (MMPs), which in turn have been associated with increased rates of embryo implantation failure. The inflammatory status of the urogenital niche in turn affects the receptivity of the uterus and embryo implantation, and thereby IVF success. Proteomics (O-Link analysis) To investigate the inflammatory state of the asymptomatically dysbiotic and healthy women in the screening cohorts, O-link analysis (BioXpedia, Aarhus, DK) was performed. O- link is a highly specific, targeted proteomics method, in which qPCR is performed on proteins by using antibody-linked oligonucleotides. Different panels of multi-well plates are available that target different subsets, such as the inflammation panel used here to quantify 92 inflammatory markers. A clear separation based on inflammatory protein markers was observed between the dysbiotic and healthy groups in the screening cohort (Figure 8A). Only one healthy microbiome sample clustered with the dysbiotic samples, which could be due to an undetermined infection that is not picked up by bacterial metagenome sequencing, such as, e.g., Candida (this data was generated pre-gynecological examination and pathogen screen, and all women were asymptomatic).

123  \\4163‐8733‐4730  v3      Transcriptomics (NanoString) To investigate the inflammatory state of the asymptomatically dysbiotic healthy women in the intervention cohort, NanoString nCounter technology (NanoString Technologies, Seattle, Washington) was applied to a subset of samples obtained from the healthy and dysbiotic subjects. NanoString uses a highly specific, targeted transcriptomics method in which individual mRNA molecules of an mRNA library are complexed with a uniquely barcoded complementary reporter probe before immobilization and detection via fluorescence. Different panels of reporter probes are available, such as the inflammation panel used here to quantify 579 inflammatory markers. A clear separation based on inflammatory mRNA markers was observed between the healthy donors and dysbiotic baseline recipients (Figure 8B). Metabolomics (untargeted) To explore using metabolomics to investigate the difference between the asymptomatic dysbiotic, and healthy women in the intervention cohort, untargeted metabolomics (by MS- Omics Aps, Vedbæk, Denmark) using liquid chromatography/mass spectrometry was used to identify and characterize 879 small molecules in a subset of dysbiotic and healthy donor samples. A clear separation based on metabolic markers was observed between the healthy donors and dysbiotic baseline recipients (Figure 8C). The vaginal niche thus differs in healthy and asymptomatically dysbiotic women on RNA, protein and metabolite level. Several proinflammatory cytokines were upregulated in the dysbiotic participants, such as IFNγ, IL-1α, IL-12, IL-18, and MMP-10 (Figure 8D; Moscicki A-B, Shi B, Huang H, et al. (2020) Front. Cell. Infect. Microbiol.10:569022.; Clara Aranha, Mayuri Goriwale, Shahina Begum, et al. (2022) Journal of Obstetrics and Gynaecology.; Jespers V, Kyongo J, Joseph S, et al. (2017) Scientific Reports 7: 11974.; Campisciano G, Zanotta N, Licastro D, et al. (2018) Scientific Reports 8:2307.; and Lannon SMR, Vanderhoeven JP, Eschenbach DA, et al. (2014) Reproductive Sciences 2014, Vol.21(10) 1215-1227)), which belong to Th1 cytokines (IFNγ, IL-12), innate/inflammasome-associated cytokines (IL-1, IL-18), and metalloproteinases (e.g., MMP-10). Horizontal lines represent medians.

124  \\4163‐8733‐4730  v3      Example 8: Administration of the SCVMP reduces the inflammatory state of the vaginal niche This Example describes the change of the local induced administration of a SCVMP by changing the dysbiotic vaginal microbiome. Biobanking of donor and recipient CVS for biomarker analysis For several points in time, CVS samples taken from recipient 2 were used for Olink inflammatory biomarker analysis. Samples were processed in the same way as the biobanking samples of the screening cohort in Example 7. For each donor, the 5 th visit was not used for SCVMP preparation but instead processed according to the biobanking method. This yielded a number of aliquots for the sole purpose of biobanking. Inflammatory protein analysis Prior to administration of the SCVMP to the recipient, the samples of all dysbiotic subjects clustered together by O-link proteomics, transcriptomics and metabolomics (Figures 8A, 8B and 8C). In Figures 8A, 8B, 8C each data point (e.g. square, circle, triangle) corresponds to the data of a healthy or dysbiotic subject, before receiving the treatment with the SCVMP of the invention. In Figure 9 each data point (solid circles, empty circles, solid triangles) corresponds to the data of a healthy or dysbiotic subject, or to a previously dysbiotic subject after receiving the treatment with the SCVMP. The knot in each cluster represents the mean of a treatment group (Figure 8 and 9). The post-treatment analysis was performed between 1 week to 3 months after the administration of the SCVMP to the dysbiotic subjects. While the clusters and means of O-link proteomics data indicate that the dysbiotic (solid circles) and healthy donor (empty circles) vaginal microbiomes are distinct from each other, after administration of the SCVMP, the cluster (solid triangles) shifted closer to the healthy donor cluster (empty circles in Figure 9), which is indicative of a successful reversal of the vaginal dysbiosis. The administration of the SCVMP thus appeared to have shifted the recipient’s vaginal microbiome from a dysbiotic microbiome towards the microbiome of the healthy donor (Figure 9). Though limited by the small number of available data points, selected pro-inflammatory markers that were differentially expressed in dysbiotic and healthy cohorts (Figure 8 D) were either not changed or showed a trend of being downregulated post-administration (data not

125  \\4163‐8733‐4730  v3      shown), suggesting that the treatment of dysbiosis by administration of the SCVMP may treat or ameliorate local inflammation in the vaginal cavity. Example 9: Clinical studies This Example describes the clinical study aimed at evaluating the efficacy of promoting implantation in a female subject undergoing in vitro fertilization (IVF) by using a SCVMP or a pharmaceutical composition comprising the same as provided herein, wherein the subjects have vaginal dysbiosis. A schematic of the clinical trial is provided in Figure 11. Donor subject selection criteria A substantially complete vaginal microbial preparation will be obtained and screened as described above. The donors undergo a stringent screening and follow-up procedures as described above. Great precaution is taken in order to avoid the transfer of sexually transmitted diseases or infections to the recipients by the administration of the pharmaceutical composition and to confirm that the microbiota composition of the donor CVS is lactobacilli dominant. Patient (recipient subject) eligibility criteria Inclusion criteria: To be eligible for inclusion, the participant must fulfil all of the following criteria: 1. Be able and willing to give written informed consent. 2. Planning and approved to undergo IVF treatment and frozen embryo transfer (FET). 3. Be generally healthy, as determined by the investigator. The following criteria apply to Arm A (n=20) and Arm B (N=20) only 4. Meet the following pre-defined criteria of vaginal dysbiosis: Combined Lactobacilli relative abundance below 10 % AND combined relative abundance of Gardnerella + Atopobium + Prevotella above 20 % based on metagenomic sequencing of vaginal sample. 5. Euploid embryo for transfer confirmed by preimplantation genetic screening (PGS). 6. Is willing to be asked questions about personal medical, sexual, and behavioural history. 7. Is willing to self-collect cervicovaginal secretions and vaginal swab samples at the clinic. The following criteria apply to Arm B (N=20) only 8. Is willing to undergo three administrations of the pharmaceutical composition comprising the SCVMP.

126  \\4163‐8733‐4730  v3      9. Is willing to abstain from vaginal intercourse, unless using condoms, without the use of adjunctive spermicide or lubricant following the administrations of the pharmaceutical compositions until embryo transfer. 10. Is willing to avoid swimming, sitting in a hot tub following the administrations of the pharmaceutical compositions until embryo transfer. 11. Is willing to abstain from using insertive vaginal feminine products (e.g., tampons, menstrual cups, sex toys), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the study investigators following the administrations of the pharmaceutical compositions until embryo transfer. Exclusion criteria: The presence of any of the following criteria will exclude the participant from participating in the study: 1. Women in relationship with a male where the male partner is evaluated to be the main reason of need for IVF 2. Participants who have HIV/AIDS or other immunodeficiency. 3. Participants who test positive at screening for HIV, chlamydia, gonorrhoea, Mycoplasma genitalium, and/or trichomonas vaginalis. 4. Participants with a current vaginal Candida infection requiring treatment. 5. Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental study, these must have been completed not less than 30 days prior to this study. 6. Participants with any known condition requiring regular use of antibiotics, that would suggest the participant is likely to require antibiotic treatment during the study. 7. Systemic and/or vaginally applied antibiotic use within the last month prior to screening – not including prophylactic use of antibiotic following egg retrieval or antibiotic use that, in the opinion of the investigator, would not impact the outcomes of the study. 8. Participants with any social, medical, or psychiatric condition that in the opinion of the investigator would make it unlikely for the participant to comply with the study or would complicate interpretation of data from her participation.

127  \\4163‐8733‐4730  v3      9. Participants with a history of drug or alcohol abuse that in the opinion of the investigator would make it unlikely for the participant to comply with the study or would complicate interpretation of data from her participation. 10. Participants with a history of gynaecological cancers, gynaecological conditions, or surgical gynaecological medical history, which, in the opinion of the investigator, precludes participation. Participants with abnormal finding on screening exam or any other condition, which, in the opinion of the investigator, precludes participation. Study design The clinical study is a non-randomized, single-site, open-label, three-armed, sequential control and active arm study in women planning to undergo IVF who have asymptomatic, vaginal dysbiosis. The study will investigate the change in relative abundance of lactobacilli by administering a SCVMP from healthy donors to women with a low relative abundance of lactobacilli (vaginal dysbiosis) that plan to undergo IVF treatment. The study will further investigate the effect of the reversal of vaginal dysbiosis on the success rate of embryo implantation in the participants undergoing IVF. It will involve up to 7 study visits over a period of up to 7 months. The study will investigate three cohorts A, B and C. Arm A: 20 women who pass all screening criteria, control group for sample collection but no medical intervention Arm B: 20 women to pass all screening criteria, who will receive active medical intervention in the form of administration of the pharmaceutical composition as described herein. Arm C: Up to 150 women with normal/healthy vaginal microbiomes, wherein only pregnancy outcome data obtained after screening, no sample collection, no intervention. Treatment The pharmaceutical composition administered to the subjects comprises the SCVMP described herein from a healthy donor, wherein approx.0.3 ml or about 600 mg of the cervicovaginal secretion comprised in the preparation is mixed with approx.1 ml of sterile saline. Each CVS sample collected from donors also needs to satisfy the following criteria to be released and used for therapy: ^ pH < 4.5

128  \\4163‐8733‐4730  v3      ^ Metagenomic sequencing of sample showing a combined vaginal Lactobacillus relative abundance above 80 % and combined Gardnerella, Atopobium and Prevotella relative abundance below 5 %. ^ Colony forming units (CFU) ≥ 1*10 5 per dose ^ No sperm cells observed by either microscopy or detected in sample based on lab analyses (acid phosphatase test) The pharmaceutical composition will be thawed from -80° Celsius storage to room temperature shortly (same day) before use. The sample is transferred to a sterile, single-use syringe and applied to the vagina of the participant by the clinical study personnel while the subjects is positioned in the Lithotomy position (e.g., by insemination catheter). The participant remains in a supine position for at least 30 minutes after the administration of then pharmaceutical composition. Results ^ The rate of clinical pregnancy among participants that have received the pharmaceutical composition (Arm B) versus control subjects (Arm A; Arm C) assessed as ultrasound- confirmed fetal heartbeat at visit 7 (8 weeks after embryo transfer). ^ The implantation rate at embryo transfer (Number of gestational sacs seen divided by number of embryos transferred) between groups. ^ The rate of clinical pregnancy in women screened to have healthy vaginal microbiomes (Arm C) compared to women screened to have vaginal dysbiosis (Arm A). ^ The rate of biochemical pregnancy in women screened to have healthy vaginal microbiomes (Arm C) compared to women screened to have vaginal dysbiosis (Arm A). ^ The rate of biochemical pregnancy among participants that have received the pharmaceutical composition (Arm B) versus control subjects (Arm A; Arm C) assessed as positive hCG at visit 6 (2 weeks after embryo transfer). ^ The change in microbiome in Arm B versus the control arm (Arm A) in terms of relative abundance of combined Lactobacillus species measured by metagenomic sequencing of vaginal samples obtained from Visit 2 (baseline) to visit 5-7. ^ The number of participants in Arm B where vaginal presence of Lactobacillus strains originating from the SCVMP donor product can be identified in the period from visit 5-7.

129  \\4163‐8733‐4730  v3      ^ The change in microbiome after administration of the pharmaceutical composition (Arm B) versus control subjects (Arm A) in terms of relative abundance of combined pathogen relative abundance (Gardnerella, Atopobium, and Prevotella) measured by metagenomic sequencing of vaginal samples obtained at Visit 2 (baseline) to visit 5-7. ^ The change in pH in cervicovaginal secretions after administration of the pharmaceutical composition (Arm B) versus control subjects (Arm A) obtained at Visit 2 (baseline) to visit 5-7. ^ The change from Visit 2 (baseline) to visit 5-7 in immune and inflammatory biomarkers in CVS after administration of the pharmaceutical composition (Arm B) subjects versus control subjects (Arm A). Example 10: Multiparameter assessment of various dosage formulations using simulated vaginal fluid A variety of suitable dosage forms was assessed for formulating the SCVMP described herein, including formed gels, lyophilized gels, tablets, and films. A number of excipients were assessed to achieve suitable dosage forms, including mannitol, micro-crystalline cellulose, mucin (porcine, Sigma), hyaluronic acid (Sigma), maltodextrin, Guar gum (Sigma), inulin (Sigma), alginic acid (sodium alginate, Dupont), polyvinyl alcohol (PVA Parteck SRP 80, Merck), sodium CMC (Ac-Di-sol, sodium carboxymethyl cellulose, DuPont), polyvinylpyrrolidone (Kollidon (PVP), BASF), hydroxypropyl methylcellulose (Methocel K4M (HPMC), Colorcon), poloxamer (poloxamer 407 (Kolliphor), BASF), Carbopol (Carbopol 934, Serva), lactic acid, and acetate buffer. Basic formulations Formed gels were prepared using the excipients including, e.g., hyaluronic acid, sodium alginate, HPMC / PVP, and poloxamer 407. The gels were pH adjusted to maintain a pH about pH 3.4 – pH 3.9. A combination of lactic acid and acetate buffers were assessed. Tablets were prepared using the excipients such as bulking agents including, e.g., microcrystalline cellulose, HPMC / PVP, maltodextran, and poloxamer 407 and compression. Lyophilized excipients were also evaluated to determine if mucoadhesion and/or gelling is improved. A combination of lactic acid and acetate buffer salts was assessed for inclusion. Tablet tensile strength was targeted at about 1.0 MPa, to ensure lack of excessive breakages and good

130  \\4163‐8733‐4730  v3      processability. The target for pH of a reconstituted tablet (e.g., inside the vaginal cavity) was about pH 3.4 – pH 3.9. The disintegration profile in a low liquid volume environment (e.g., inside the vaginal cavity) was also assessed. For lyophilized gels, a number of excipients were lyophilized, including, e.g., hyaluronic acid, sodium alginate, HPMC / PVP, and poloxamer 407. All gels were pH adjusted to maintain a pH about pH 3.4 – pH 3.9. A combination of lactic acid and acetate buffers were assessed. The target lyophilized appearance was a clean, uniform cake. The target water content was generally less than 3% w/w water (e.g., to increase viability of drug substance). The target reconstitution time in a vial was less than 2 minutes with hand swirling. For films (air-dried) PVA in various concentrations was assessed. For example, PVA was supplemented with sodium CMC and other excipients to modify drying times, final flexibility of films, mucoadhesion etc. A combination of lactic acid and acetate buffers was assessed, and pH effect on immersion in simulated vaginal fluid evaluated. The target film properties included sufficient flexibility for application (e.g., to the vaginal tract), non-tackiness, acceptable drying times for ease of processing, a suitable film thickness, and disintegration profile in a low liquid volume environment (e.g., inside the vaginal cavity), as well as effective release and engrafting of drug substance. The target for pH of a reconstituted film (e.g., inside the vaginal cavity) was about pH 3.4 – pH 3.9. All components were assessed for optimisation of viscosity (e.g., at 37 ⁰C, e.g., inside the vaginal cavity), enhancement of mucoadhesion (e.g., to epithelial, mucosal surfaces e.g., inside the vaginal cavity) and/or positive impact on drug substance stability (e.g., bacterial viability upon formulation and storage). Ideal formulations show little to no flow on suitable vertical surfaces and maintain high bacterial viability (e.g., CFU count) both upon formulation and during (long-term) storage. Formulation selection parameters that were assessed included: Mucoadhesion (of reconstituted product, e.g., in the vaginal tract); viscosity (of reconstituted product), e.g., final viscosity for gel-based product needs to be syringeable at ambient temperature and preferably congealed at 37 ⁰C (at body temperature, e.g., in the vaginal tract); total sugar content (of reconstituted product), e.g., ideally at or lower than physiological concentration (about 0.5 – 1.0 mg/mL); volume of reconstituted product, e.g., up to 3 mL; hydration rate / disintegration rate (e.g., of gel/matrix), e.g., sufficient physical integrity to provide desired release rate; pH, e.g.,

131  \\4163‐8733‐4730  v3      between about pH 3.4-3.9 (e.g., to promote inhibition of competitive vaginal bacteria); water activity / moisture content (e.g., of dried formulations), e.g., between 0.5 – 3% water (e.g., for longer term dried formulation stability); microbial diversity, e.g., relative abundance of Lactobacillus species, such as, e.g., L. crispatus, L. gasseri, L. jensenii, and L. iners; total dose / potency, e.g., preferably above 1x10 5 CFU/VCC, above 1x10 6 CFU/VCC, above 1x10 7 CFU/VCC, or above 1x10 8 CFU/VCC per administration (per dose), shelf-life (not reconstituted) at various temperatures, and microbial limits, e.g., absence of microorganisms such as, Pseudomonas aeruginosa, Candida albicans, Staphylococcus aureus, Ph Eur criteria 5.1.4, 2.6.12 & 2.6.13). Testing was performed using standard assays, including plate count (e.g., MRS agar) or viable cell count (VCC, e.g., using Quantom Tx automated counting system (AM620) with fluorescent stain), e.g., for life bacteria count, dose determination, shelf-life; rheometer, e.g., for mucoadhesion and viscosity, pH meter, Karl Fisher / water activity meter, Ph Eur testing, e.g., for microbial loads. Gel Formulations Gel formulations were prepared with the following excipients: • Hyaluronic Acid at 0.5% and at 2% • HPMC + Carbopol + PVP • Poloxamer 20% + Sodium Alginate 2% • PVA 3% + NaCMC 2% • Poloxamer 20% + Guar gum 2% • Guar gum at 0.5% and 2% • Mucin 5% • Inulin 8% Flow rates (viscosity, mPa x sec / shear rate 1/sec) under gravity at ambient temperature were determined with 0.5mL on a 56 mm glass slide for Hyaluronic acid 0.5%, HPMC Kollidon 25+ Carbopol, Guar gum 0.5%, Simulated mucus and inulin. Values obtained ranged from 300 to 1x10 7 mPa x sec at shear rate of 0 to 3 to 7,000 mPa x sec at a shear rate of 1001/sec, depending on formulation. Guar gum (0.5%) and hyaluronic acid (0.5%) did not appear to form gels, yielding low viscosities. Viscosity against temperature from 15 to 45 ⁰C (with fixed shear rate of 10s-1) was also determined. Poloxamer showed a thermo-reversible gelling behaviour

132  \\4163‐8733‐4730  v3      with an increase in viscosity at about 25 ⁰C (from about 10,000 to about 12,000 mPa x sec, while other formulations mostly showed small changes in their viscosities at various levels between about 500 and 12,000 mPa x sec at 15 ⁰C and about 200 to 11,000 at 45 ⁰C, depending on formulation. The next step included and assessment which of the gel bases could be lyophilized and reconstituted to form an acceptable gel. The appearance of a ‘cake’ was also evaluated to indicate homogeneity. A simulated vaginal fluid (SVF) was produced, with the following composition: 35 mg of NaCl, 14 mg of KOH, 22 mg of calcium hydroxide, 20 mg of lactic acid, 10 mg of acetic acid, 1.6 mg of glycerol, 50 mg of glucose into 10 mL of water, adjusting to pH 4.2 using HCL. Single vials were used to simulate a single cervico-vaginal secretion donation with SVF, and volumes used were considered as representative of the range of ~0.5 mL to 1.5 mL expected from a typical donation. After suitable excipients were determined, these excipients were used to form gels by adding 1.5mL of SVF. The addition of SVF allowed correct pH balance and simulate the addition of a substantially complete vaginal microbial preparation to the excipient base. Samples were hand-shaken within vials to form homogenous gels and then lyophilized. Some excipients produced acceptable appearance post-lyophilisation. PVA, Guar gum and HA, formed acceptable (clear) gels; Kolliphor P 407 (Poloxamer 407) and Methocel K4M formed white, crystalline cakes; maltodextrin and PVP displayed discolorations (e.g., yellow), whereas sodium alginate, mucin, and NaCMC produced non-uniform cakes with discolorations (e.g., brown). Surprisingly, mannitol which typically forms consistently acceptable cakes, was crystalline which is probably due to the salt contents in the SVF. The resulting gels were reconstituted with 1.5 mL deionised water post lyophilisation. HA, guar gum and PVA reconstituted easily, with reconstitution times of 2:30 min, 2:30 min, and 1:30 min, respectively. HA formed a homogenous gel with a pH of 4.6. Guar gum formed a non-homogenous gel with a pH of 4.5. PVA formed a homogenous liquid with some foaming with a pH of 4.7. PVP, NaCMC, poloxamer, sodium alginate and HPMC formed semi- homogenous gels. All required more than 3 minutes for reconstitution. PVP dissolved slowly with a pH of 4.1. NaCMC formed a non-homogenous viscous liquid with a pH of 4.9. Poloxamer displayed some foaming with a pH of 5.4. HPMC formed a gel with some foaming with a pH of

133  \\4163‐8733‐4730  v3      4.4. Sodium alginate was non-homogenous with a pH of 5.5. Mannitol formed a homogenous liquid with some crystals remaining with a pH of 4.4. A muco-adhesion test was conducted to study the effect under gravity of the drug product when applied. For this, a mucosal surface (such as would be present in the vaginal cavity) was simulated.500 mg of mucin was compressed into disc a with a flat 2 cm tooling to approximately 3 tons of pressure. These were then adhered to a substrate, e.g., the bottom of a plastic box. Each disc was then wetted with approximately 200 µL of deionised water and rubbed with a gloved finger until the surface of the mucin became tacky to the touch. About 0.5 mL of sample (or the complete dosage unit, in the case of tablets and PVA films) was then applied in the horizontal position and allowed to settle for 2 minutes. The box was then raised so that samples were in a vertical position, and a visual assessment was taken with respect to adherence properties (muco-adhesion test) of the Guar gum, poloxamer, mannitol, PVP, hyaluronic acid, sodium alginate, CMC, HPMC, and PVA gel samples. Hyaluronic acid, NaCMC, sodium alginate and HPMC showed the best muco-adhesion in this test. As poloxamer showed thermo-reversable behavior in earlier tests, the muco-adhesion testing was repeated on a pre-heated plastic box and mucin disc at 37⁰C. It was confirmed that the gel that formed was more viscous than at ambient temperature and retained on the surface of the wetted mucin disc. This indicates that the poloxamer may be at suitable viscosity at body- temperature. Syringeability was also assessed following adjustment of concentrations: 3% (45mg) carbopol, 4% (60mg) sodium alginate, 3% (45mg) HPMC & 1.9% (30mg) sodium CMC, and 24% (360mg) poloxamer. These were prepared using an SVF:lactate buffer mix. The inclusion of a lactate buffer in the pH range of ~3.4 – 4 may promote engraftment of the lactic acid bacteria in vivo (e.g., in the vaginal tract), e.g., potentially by minimizing the competition of undesirable bacterial taxa resident in the existing microbial niche. Excipient were mixed with 1.5mL SVF+lactate buffer. Carbopol and poloxamer both formed homogenous gels after hand shaking with some air bubbles which dispersed when settled. Sodium alginate and HPMC + Na- CMC did not form homogenous gels. A lyophilized gel format as a dosage form for the substantially complete vaginal microbial preparation can, for example, be produced by blending with excipients followed by lyophilization and packaging, e.g., in vials. The vials can then be reconstituted, e.g., in a clinic

134  \\4163‐8733‐4730  v3      setting, with water to form a gel in the vial prior to application of the reconstituted drug product, e.g., by using an applicator, such as a syringe, to administer the composition comprising the substantially complete vaginal microbial preparation to the vaginal tract of a subject. A frozen gel describes a dosage form for the substantially complete vaginal microbial preparation that is blended with gelling excipients (optionally along with a suitable lactate buffer) and the liquid gel form is then frozen (at -80⁰C) and stored in either a vial or a pre-filled syringe, see, e.g., Fig.13. Tablet evaluation In addition to gels, tablet-pessaries were generated as an additional dosage form. The following aspects were considered: choice of excipient suitable for compression to form tablets and for lyophilisation, as well as to provide acceptable level of mucoadhesion, optional inclusion of lactate buffer with a pH target of about pH 3.5-4, optionally with the aim to have a single tablet prepared from individual cervico-vaginal fluid donations. All of the assessed excipients which produced both acceptable gel formation and acceptable lyophilisation (e.g., to form a reasonably free-flowing powder for further processing) were evaluated (alongside additional excipients) for tabletting quality on a manual tablet press, including Carbopol, HPMC, gelatine, sodium alginate, poloxamer, NaCMC, and pectin. Tablets were compressed at about 1 ton a with 5.5 mm tooling to form tablets. Tablets were gently added to wetted mucin discs and muco- adhesion assessed, as described earlier. All tablets remained attached for over 5 minutes. Tablets were rinsed every minute to assess impact of adhesion. NaCMC began to swell into a gel. Tablets of carbopol, HPMC, alginate, NaCMC showed sufficient tablet integrity. Poloxamer formed a tablet but with relatively low strength. Pectin and gelatine tablets showed low hardness and some brittleness. Polymeric films Film forming/casting is a potential route of preserving viability in live biological materials. To investigate this, the following excipient test samples were generated: - PVA 3% - PVA 20% - PVA 3%, NaCMC 2% - PVA 20%, NaCMC 5%

135  \\4163‐8733‐4730  v3      All samples were mixed as necessary to make a gel/film and transfer into plastic blister pack (size 0) and were stored at ambient conditions for about 48 hours to set. Both samples containing 3% PVA did not form suitable films. Films containing NaCMC displayed brittleness and were difficult to remove from the blister mould. The 20% PVA sample did form a film and could be removed with ease from the blister mould. The film was flexible and resistant to tearing. To evaluate whether forming a film with the inclusion of substantially complete vaginal microbial preparation is feasible, a ‘sandwich’ approach to film preparation was tried. This was performed in an upturned Karl Fischer lid (with PTFE lining), to produce a mould with a flat disc design. A 12% PVA solution (from the previous 20%) was used to reduce the initial viscosity and allow more consistent sample preparation via pipette. Preparation was performed as follows: 0.25 mL of 12% PVA was pipetted into each mould, followed by 0.5 mL of SVF (to simulate a substantially complete vaginal microbial preparation). Another 0.25 mL of 12% PVA was pipetted on top to complete the ‘sandwich’. The moulds were left to solidify. After about 48 hours, discs were formed, which were flexible and left no apparent residue on the PTFE lining. This suggests that the PTFE may be a suitable material for moulding, the film was easily recovered from this surface. Films were gently added to mucin discs and muco-adhesion assessed, as described earlier. The PVA discs showed no movement from the mucin surface, indicating good muco- adhesion. A wash of about 2 mL of SVF was performed after 5 minutes, which did not displace the PVA discs from the mucin surface. Table 6: Formulation summary Excipient Functionality Tablet Lyophilized / Film-form )

136  \\4163‐8733‐4730  v3      Guar gum Bulking agent, prebiotic / + + - viscosity agent + potentially suitable for dosage form - not suitable for dosage form Example 11: Formulations of dosage forms comprising a SCVMP Based on excipient data obtained from the formulation work using a simulated vaginal fluid (Example 10) and the viability testing performed (data not shown), a number of formulations were generated that contained SCVMPs (SCVMP). Lyophilized gel 1: The formulation comprised NaCMC and a SCVMP and was subjected to lyophilization. 30 mg of NaCMC was weighed and transferred into a lyophilization vial.1 SCVMP was transferred into the lyophilization vial.1 mL lactate buffer was used to rinse and take out any remaining SCVMP from its vial and this was then transferred to the lyophilization vial. The vial was capped and swirled by hand to form a homogeneous gel that was then freeze-dried.

137  \\4163‐8733‐4730  v3      Lyophilized gel 2: The formulation comprised poloxamer and a SCVMP and was subjected to lyophilization. 240 mg of Poloxamer 407 was weighed and transferred into a lyophilization vial.1 SCVMP was transferred into the lyophilization vial.1 mL lactate buffer was used to rinse and take out any remaining SCVMP from its vial and this was then transferred to the lyophilization vial. The vial was capped and swirled by hand to form a homogeneous gel that is then freeze- dried. Frozen gel 1: The formulation comprised hyaluronic acid and a SCVMP and was subjected to freezing at -80 ⁰C. 45 mg of hyaluronic acid was weighed and transferred into a lyophilization vial.1 SCVMP was transferred into the lyophilization vial.1 mL lactate buffer was used to rinse and take out any remaining SCVMP from its vial and this was then transferred to the lyophilization vial. The vial was capped and swirled by hand to form a homogeneous gel that was then frozen at -80 ⁰C. Frozen gel 2: The formulation comprised poloxamer and a SCVMP and was subjected to freezing at - 80 ⁰C. 240 mg of poloxamer 407 was weighed and transferred into a lyophilization vial.1 SCVMP was transferred into the lyophilization vial.1 mL lactate buffer was used to rinse and take out any remaining SCVMP from its vial and this was then transferred to the lyophilization vial. The vial was capped and swirled by hand to form a homogeneous gel that was then frozen at -80 ⁰C. Lyophilized tablet 1: The formulation comprised NaCMC and a SCVMP and was subjected to lyophilization. 30 mg of NaCMC was weighed and transferred into a lyophilization vial.1 SCVMP was transferred into the lyophilization vial.1 mL lactate buffer was used to rinse and take out any remaining SCVMP from its vial and this was then transferred to the lyophilization vial. The vial was capped and swirled by hand to form a homogeneous gel that is then freeze dried. Once lyophilized, 300 mg of NaCMC were added to substance and compressed to 1 ton.

138  \\4163‐8733‐4730  v3      Lyophilized tablet 2: The formulation comprised poloxamer and a SCVMP and was subjected to lyophilization. 30 mg of Poloxamer 407 was weighed and transferred into a lyophilization vial.1 SCVMP was transferred into the lyophilization vial.1 mL lactate buffer was used to rinse and take out any remaining SCVMP from its vial and this was then transferred to the lyophilization vial. The vial was capped and swirled by hand to form a homogeneous gel that was then freeze- dried. Once lyophilized, 300 mg of PVP (Kollidon) were added to substance and compressed to 0.5 ton. PVA film disk The formulation comprised 12% PVA and a SCVMP sandwiched between two PVA layers (approximately 0.25 mL of PVA per layer). Viable cell counts (VCC) were determined at t=0 after formulating the SCVMP. Viability after 1 month and 2 months is also being determined and both VCC and CFU are assessed. Table 7: Viable cell counts at t=0 after formulation. Formulation Donor #/ CFU of Species Viable cell 139  \\4163‐8733‐4730  v3      SCVMPs can be lyophilized and formulated into, e.g., gels and tablets as well as other dosage forms that can be filled with lyophilized products, such as, e.g., capsules. SCVMPs can also be formulated into gels that can be frozen, as well as into liquid media (e.g., with glycerol) that can be frozen. SCVMPs can also be formulated into (air-dried) films, that could be, e.g., shaped like disks. Losses in viability range from approximately 0.5 log to 1 log at the formulation step depending on excipient and dosage form. Example 12: Associations between the vaginal microbiome, inflammatory status and outcome – a study in women undergoing frozen embryo transfers Example describes an observational study that identified differences in vaginal microbiome composition in pregnant and non-pregnant women who underwent an in vitro fertilization (IVF) procedure with a frozen embryo transfer (FET). Specifically, this study allowed for the investigation of (a) the prevalence of vaginal dysbiosis among women undergoing FET IVF procedures in the U.S.; (b) the association between vaginal microbiome composition and pregnancy outcomes in women who have undergone FET IVF treatment (outcomes including biochemical pregnancy, clinical pregnancy, miscarriage, pre-term birth, successful birth at term); and (c) the association between immune biomarkers and pregnancy outcomes in women who have undergone FET IVF treatment. A single-center study was performed in which samples of cervicovaginal secretions (CVS), vaginal swabs, urine and menstrual effluent were obtained from a total of 190 women of reproductive age (18-44) undergoing an IVF cycle with FET. Participants in the study were not taking antibiotics at time of sample collection, had any known condition requiring regular use of antibiotics, or had systemic and/or vaginally applied antibiotic use within 30 days of sample collection for menstrual effluent and/or vaginal samples obtained during treatment cycle (except for prophylactic antibiotics related to egg retrieval). Additionally, participants in the study had not taken probiotic vaginal suppositories or steroids within 30 days of sample collection for menstrual effluent and/or vaginal samples obtained during treatment cycle. CVS collection of vaginal fluid, vaginal swabs and a urine sample were collected 0 to 10 days before a frozen embryo transfer. The bacterial composition of the vaginal microbiome of each participant was determined using the collected samples obtained before FET. Specifically, the relative abundance of three

140  \\4163‐8733‐4730  v3      Lactobacillus spp. (Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii) were determined for the vaginal microbiome of each participant. Pregnancy success after FET was subsequently determined for each participant. Based on pregnancy success/failure of each participant, it was determined that pregnancy success could be modeled using XGBoost (a gradient boosting machine learning technique) on a number of features, including the number of previous failed IVF cycles, the number of previous pregnancy losses, participant’s age, and the relative abundance of Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii in the vaginal microbiome of each participant. It was found that one or fewer prior IVF cycles was a strong predictor of IVF success, as evidenced by the positive SHAP value for women in those two groups (Figure 12A). It was also found that among women with two or fewer prior IVF cycles, two or fewer prior lost pregnancies (e.g., miscarriages) was a predictor of IVF success (Figure 12B). Finally, among women with two or fewer prior IVF cycles and two or fewer prior lost pregnancies (e.g., miscarriages), an age of 42 or less was a predictor of IVF success (Figure 12C).68% of the total cohort fulfilled all three of these criteria (two or fewer prior IVF cycles, two or fewer prior lost pregnancies (e.g., miscarriages), and an age of 42 or less). In the women who met these criteria, it was found that pregnancy success was predicted in individuals with a combined relative abundance of Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii in the vaginal microbiome that was greater than 90% as determined by metagenomic sequencing (Figure 13). This is evidenced by the positive SHAP value shown in Figure 13 for a combined relative abundance of 90% or greater Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii in the vaginal microbiome. This finding can be used to define a microbial state of vaginal dysbiosis that is applicable to IVF success. The data suggest that vaginal dysbiosis can be defined as the combined relative abundance of less than 90% Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii in the vaginal microbiome. In addition to determining the relative abundance of bacterial species in the vaginal microbiome, the vaginal samples of 260 participants were assessed for their immunological profiles using microbiome and RNA expression assays. These participants matched the microbiome predictive criteria (two or fewer prior IVF cycles, two or fewer prior lost pregnancies (e.g., miscarriages), and an age of 42 or less) described above. The microbiome was

141  \\4163‐8733‐4730  v3      characterized using metagenomic sequencing to determine the relative abundance of bacterial species and RNA expression was measured for 634 oncological and immunological associated targets using an nCounter panel and assay. Participants with greater than a 95% combined relative abundance of L. crispatus, L. gasseri, and L. jensenii were found to have a distinct immunological profile compared to participants with less than a 95% combined relative abundance of L. crispatus, L. gasseri, and L. jensenii, as demonstrated by principal component analysis (Figure 16A). Specifically, 167 genes were significantly differentially expressed between the two populations, including selected pro-inflammatory or inflammasome-associated cytokines (IL-1α, IL-1β, IL-2, IL-5, IL-8, IL-15, IL-17, IP-10, COX-2, and VEGF), selected Th1 cytokines (IFNγ, IL-12, and STAMBP), IL-4, TGFβ, and chemokine ligand 5 (CCL5). These data demonstrate that there is predictive value for IVF success in a determination of the immunological profiles of women. Example 13: A trial with a substantially complete vaginal microbiota preparation the efficacy of using a substantially complete vaginal microbiota preparation as provided herein as a treatment of vaginal dysbiosis. The primary objective of the study was to evaluate the effect of three sequential substantially complete vaginal microbiota preparation doses from healthy donors to healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined from metagenomic sequencing of a vaginal swab sample. Administration of the substantially complete vaginal microbiota preparation was performed at 3 visits on 3 consecutive days and subjects and their vaginal microbiomes were followed until approximately 6 months after the first dose. The study was a single-site, randomised, double-blind, placebo- controlled, two- armed, parallel-group study in healthy female subjects aged 18-45 years. A schematic of the clinical trial is provided in Figure 17. The female participants having vaginal dysbiosis (i.e., less than 90% total relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri in the vaginal microbiome) at screening underwent intervention with vaginal administration of either a substantially complete vaginal microbiota preparation (SCVMP) (“active”) as described herein

142  \\4163‐8733‐4730  v3      (n=26) or placebo (saline) (n=8) on 3 consecutive days. The change in vaginal microbiome in terms of relative abundance of selected, combined Lactobacillus species (crispatus, gasseri, and jensenii) measured by metagenomic sequencing was assessed at time points ranging from 1 week to 5 months after baseline (day 0). It was found that participants who were treated with the SCVMP had a significant increase in the combined relative abundance of Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii in the vaginal microbiome. Furthermore, it was determined that participants who were treated with placebo did not exhibit a similar change in the combined relative abundance of Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii in the vaginal microbiome. See, Table 8. Table 8. Relative abundance of L. crispatus, L. gasseri, and L. jensenii in the vaginal microbiome of study participants Change from baseline Relative abundance (mean ± SEM) (comparison between Statistical significance was observed up to 24 weeks after administration of SCVMP as compared to placebos (Table 4, Figure 14). In addition, the L. crispatus single nucleotide variant (SNV) profile of recipient CVS (i.e., the participant) was compared to all the donor CVS (i.e., the SCVMP) samples. L. crispatus SNVs were identified using CVS metagenomic sequencing reads aligned to a L. crispatus reference genome using metaSNV. Manhattan dissimilarities were calculated between each set of

143  \\4163‐8733‐4730  v3      recipient samples and every donor sample used in the study. Distances between samples from the same donor were averaged together. After administration of the SCVMP, the average dissimilarity between recipient L. crispatus SNV profiles and the SNV profiles of samples from the donor they received were lower than the average dissimilarity between recipients and every other donor (i.e. not their donor) (Figure 15). This demonstrates that when L. crispatus is detected in the recipient after SCVMP administration its SNV profile is more similar to the donor sample they received than other donor samples. These data suggest that the donor SCVMP is successfully engrafting into the vagina of the participant. As performed in Example 12, the immunological profile of the vaginal microbiome of participants in this study was determined following administration of the SCVMP or placebo. For individuals treated with the SCVMP, it was found that there was a distinct change in the immunological profile if the administration of the SCVMP led to a vaginal microbiome having a relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri that was 90% or greater. This indicates that changing the species composition of the vaginal microbiome provides beneficial change in immunological profile. The fold-change in the abundance of 634 biomarkers for participants treated with SCVMP who achieved a vaginal microbiome having a relative abundance of Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri that was 90% or greater following treatment, was highly correlated with the biomarker changes measured in participants of the study described in Example 12, who had a microbiome predictive of increased pregnancy success after FET compared to those without (Figure 16B). These data suggest that SCVMP administration-induced microbiome changes are leading to a biomarker profile that is associated with increased pregnancy success. Example 14: Evaluating the efficacy of SCVMP in women planning to undergo frozen blastocyst transfer This Example describes a clinical study aimed at evaluating the efficacy and safety of substantially complete vaginal microbiota preparations (SCVMP) in female subjects having asymptomatic vaginal dysbiosis and planning to undergo a frozen blastocyst transfer (FET) cycle. The SCVMP is cervicovaginal secretions (CVS) from a healthy donor diluted in sterile, saline water. The CVS donors undergo a stringent screening to avoid the transfer of sexually

144  \\4163‐8733‐4730  v3      transmitted diseases or infections to the recipients of the SCVMPand to confirm that the microbiota composition of the donor CVS is Lactobacilli dominant. The placebo is sterile, saline water. Key participant selection/inclusion criteria: 1. Be a pre-menopausal woman aged 18 to 40 years. 2. Is planning and willing to undergo a frozen blastocyst transfer with one good-quality blastocyst. 3. Is in good physical and mental health. 4. Meet the following definition of vaginal dysbiosis: a copy number measured by qPCR at a central laboratory, corresponding to less than 90% total relative abundance of Lactobacillus species crispatus, jensenii, and gasseri. 5. Has a transvaginal ultrasound showing no abnormalities considered incompatible with pregnancy or associated with a decreased probability of pregnancy. 6. Is willing to abstain from vaginal intercourse, unless using condoms. Key participant exclusion criteria: Participants 1. With no clinical pregnancy in more than two prior consecutive embryo or blastocyst transfers. 2. Who are pregnant. 3. With known immunodeficiency conditions. 4. Who test positive at screening for chlamydia, gonorrhoea, Mycoplasma genitalium, and/or Trichomonas vaginalis. 5. With a current vaginal Candida infection requiring treatment. 6. With a history of gynaecological cancers, gynaecological conditions, or surgical gynaecological medical history. 7. With abnormal finding on the physical, gynaecological, or female genital examinations or any other condition. Objectives - To evaluate (i) the change in vaginal microbiome composition, (ii) the presence of Lactobacillus strains originating from the SCVMP donor product in vaginal samples of participants, (iii) the change in endometrial microbiome composition, (iv) change in metabolic, immune, and inflammatory biomarkers in cervicovaginal secretions (CVS)

145  \\4163‐8733‐4730  v3      obtained from participants, and (v) pregnancy rates following administration of the SCVMP described herein on two consecutive days compared to placebo in women planning to undergo a frozen blastocyst transfer cycle and with asymptomatic vaginal dysbiosis confirmed at screening. - To evaluate the safety profile following SCVMP, such as adverse events including vaginal tolerability, routine safety laboratory parameters, and female genital examination. Study design This study is a randomized, double-blind, placebo-controlled, two-arm, multi-center study in women planning to undergo a frozen blastocyst transfer cycle who have asymptomatic, vaginal dysbiosis (defined as a vaginal microbiome having less than 90% relative abundance of three selected Lactobacillus species – Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii) at the microbiological level based on microbial DNA-based screening of a vaginal sample. This study enrols women who are planning to undergo a frozen blastocyst transfer cycle with a single blastocyst and with vaginal dysbiosis at the microbiological level confirmed at screening as determined by an analysis of the presence of relevant vaginal species in a vaginal sample. This study investigates the change in abundance of Lactobacilli after SCVMP administration to participants with a lower abundance of Lactobacilli (vaginal dysbiosis) who are undergoing fertility treatment. Eligible women will be randomized to one of two arms, SCVMP (active) and saline (placebo). Vaginal administration of SCVMP or placebo is performed on two consecutive days. Subjects undergo a frozen blastocyst transfer cycle in the second menstrual cycle following the administration of SCVMP or placebo. Assessment of pregnancy is performed. After the administration of either SCVMP or placebo, all participants with a clinical pregnancy will be followed until delivery to determine pregnancy rate, live birth rate, and neonatal health. Data from participants who at screening are found to have normal Lactobacillus-dominant vaginal microbiomes, and therefore not randomized into the trial and not undergoing a study-related intervention are collected to establish a baseline of pregnancy rates in the general, non-dysbiotic IVF population. Study procedures The first visit occurs two menstrual cycles before the planned frozen blastocyst transfer. A vaginal swab is obtained to screen for potential vaginal dysbiosis based on pre-defined criteria.

146  \\4163‐8733‐4730  v3      At the second (baseline) visit a baseline assessments and randomization are performed, followed by vaginal cleansing with an antiseptic (e.g., chlorhexidine) followed by the first administration of SCVMP or placebo. The following day, a second vaginal administration of SCVMP or placebo without vaginal cleansing is performed. Subjects undergo blastocyst transfer in the second menstrual cycle after administration of SCVMP or placebo. Subjects will follow standard procedures for a frozen blastocyst transfer cycle, including any hormonal medication required for a programmed or modified natural cycle (e.g., estradiol supplementation, progesterone supplementation, hCG injection, etc. as needed). Additional visits are timed to coincide with pregnancy monitoring, e.g., serum hCG test approximately 14 days after blastocyst transfer and clinical pregnancy assessment at 5-6 weeks after blastocyst transfer, respectively. Vaginal swabs are collected at all trial visits, and CVS collection, endometrial fluid aspiration, genital examination, and blood and urine collection are done at selected visits. Physical and gynaecological examinations are performed at Visit 1 and at the end of the trial. Vital signs (systolic blood pressure, diastolic blood pressure, heart rate, and temperature) are measured at the beginning and at the end of the trial. Recording of prior and concomitant medication is done at all visits. Recording of adverse events, including adverse events of special interest focusing on vaginal tolerability (e.g., odor, pain, tenderness, vulvar/vaginal itching, vulvar/vaginal itching erythema (redness), vaginal dryness, and vaginal discharge) is done at all visits. Subjects are followed up for approximately 16 weeks. Pregnancy follow-up data related to ongoing pregnancy, live birth, and neonatal health is also collected. Endpoints The change in vaginal microbiome, and endometrial microbiome of SCVMP subjects versus placebo subjects in terms of relative abundance of combined Lactobacilli species (crispatus, jensenii, and gasseri) measured by metagenomic sequencing of vaginal samples obtained from Visit 2 (baseline) to later visits. The proportion of SCVMP subjects where vaginal presence of Lactobacillus strains originating from the SCVMP donor product can be identified at various visits throughout the follow-up period. The change in vaginal microbiome of SCVMP subjects versus placebo subjects in terms of relative abundance of combined pathogen species (Gardnerella, Atopobium, and Prevotella)

147  \\4163‐8733‐4730  v3      measured by metagenomic sequencing of vaginal samples obtained at Visit 2 (baseline) and later visits. The positive serum hCG rate (defined as positive serum hCG test 14 (±1) days after frozen blastocyst transfer) in the SCVMP group and placebo group. The clinical pregnancy rate (defined as ultrasound-confirmed fetal heartbeat 5-6 weeks after frozen blastocyst transfer) in the SCVMP group and placebo group. The early pregnancy loss rate (defined as positive serum hCG test, but no clinical pregnancy) in the SCVMP group and placebo group. Frequency and intensity of adverse events, frequency and grade of female genital examination findings, changes in circulating levels of clinical chemistry and haematology parameters and proportion of subjects with markedly abnormal changes. The change in metabolic, immune, and inflammatory biomarkers in CVS of SCVMP subjects versus placebo subjects in vaginal samples obtained at Visit 2 (baseline) and later visits. The rate of positive serum hCG and clinical pregnancy in women screened to have healthy vaginal microbiomes (non-randomized group). The ongoing pregnancy rate and the live birth rate in the SCVMP group and placebo group. The neonatal health at birth, including serious adverse events at birth, in the offspring of the SCVMP subjects and of the placebo subjects. It is anticipated that this study will demonstrate an increase in IVF and FET success (e.g., increase in rates of positive serum hCG, clinical pregnancy, and live birth) in the cohort of women who are treated with the SCVMP of the disclosure compared to the cohort of women who are treated with the placebo. This increase in IVF and FET success is expected to be attributable (at least in part) because of an expected change in the vaginal microbiomes in women treated with the SCVMP in terms of relative abundance of combined Lactobacilli species (L. crispatus, L. jensenii and L. gasseri), e.g., as measured by metagenomic sequencing of vaginal samples obtained from Visit 2 (baseline) to Primary Assessment. Furthermore, it is expected that donor strains originating from the SCVMP donor product will engraft within the vaginal microbiomes of women treated with the SCVMP. Finally, it is anticipated that women treated with the SCVMP will undergo a change in metabolic, immune and inflammatory biomarkers in CVS compared to women treated with placebo.

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