FIELD

This invention relates to a device and method for assessing human fecundability, that is, the likelihood of, and/or ability for, a woman (or couple) to conceive over time.

BACKGROUND

For most couples, the chance of conceiving is generally quite good; others however may face the challenges of subfertility.

Subfertility is defined as meaning that pregnancy is possible, but that the chances have been reduced in the short term (or long term) for a variety of possible reasons.

For the average couple, there is a generally a 20-25% chance of conception per month, however only approximately 65% of couples will have conceived in the first six months - although this percentage increases to approximately 90% after 12 months. Moreover, most couples with subfertility will usually go on to conceive in time, and only 5% of couples have complete infertility (or sterility).

There are a variety of reasons for conception not happening.

About 30% of causes can be attributed to a problem with female fertility; 30% to a problem with male fertility; and in about 20% of cases there is a problem with both partners. In approximately 20% of cases, there is no clear and definitive cause for subfertility - and in these instances subfertility may remain frustratingly unexplained. However, there are now available modern fertility treatments such as In Vitro Fertilisation (IVF) which can significantly increase the chances of conception, if couples are unable to conceive on their own.

A range of lifestyle factors can influence overall fecundability. These include:

1. Age.

2. Health and wellbeing. 3. The intake of mild stimulants such as cigarettes, alcohol and caffeine.

4. Diet.

5. Emotional factors such as stress.

6. Sexually transmitted diseases.

7. Existing medical conditions. 8. Exposure to environmental toxins.

A woman's chance of conceiving each month decreases with age, especially in the late 30s and early 40s, and so age is a particularly relevant and important factor to consider.

For example, if a couple has been trying to conceive for only a few months, and the woman is under 35, and there is nothing to otherwise suggest an anatomical problem, then the couple will likely be encouraged to try a little longer before any invasive tests are performed.

However, couples that generally require longer to conceive because the woman is older, may require earlier investigations because there is less time left for conception.

For example, on average it takes three to four months for a 25-year-old woman to conceive if everything else is normal, however it takes twice this time for someone who is 35. This doubling of the time it takes to conceive over 10 years then doubles again over the next 4 years so that by the time a normally fertile woman is 39 years old, the average time to conception is about 15 months. The male's age generally exerts almost no effect until he is well over 40.

It is therefore important for couples to be able to understand (or learn) the basic physiology of conception, and the various criteria involved with successfully conceiving - especially if the woman is getting older. However, many couples have difficulty understanding the complexity of the process of conception, and furthermore different physicians may provide differing opinions as to the chances of conception, and whether intervention should be attempted - and this may prove to be confusing and frustrating for the couple.

Often, simple tests that check ovulation and sperm quality can provide reassurance to a couple that both partners are inherently fertile - and hence the couple may therefore be advised to keep trying a little longer before a more intensive investigation may become necessary. Moreover, these tests can also be useful in quickly identifying a problem.

However, many couples tend to procrastinate and/or neglect to seek professional advice until it is too late.

It would be advantageous therefore if there was available a relatively simple and easy-to- use device (and method) which could provide a couple (or health professional) with scientifically robust information regarding a couple's chances of conception, and/or when the couple should seek assistance or intervention regarding conception.

OBJECT

It is an object of the present invention to provide a device and/or method for assessing human fecundability, which goes some way towards addressing the aforementioned problems or difficulties, or which at the very least provides the public with a useful choice.

DEFINITIONS

Throughout this specification unless the text requires otherwise, the word 'comprise' and variations such as 'comprising' or 'comprises' will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. STATEMENTS OF INVENTION

According to one aspect of the present invention, there is provided a device for assessing human fecundability, said device including:

a) a base template, said base template including primary markings representative of at least one fecundability criteria of a woman and/or a couple,

b) a top template, said top template being movable with respect to said base template, whereby a first portion(s) of said top template may be positioned with respect to said primary markings on said base template,

c) means for assessing the fecundability of said woman and/or said couple based on the location of a second portion(s) of said top template with respect to secondary markings, said secondary markings being included on said base template.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said base template is substantially or wholly circular.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said top template is rotatably fixed to said base template.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said top template is rotatably fixed to said base template in the region of the centre of said base template.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said primary markings on said base template are positioned substantially around the periphery of said base template.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said primary markings on said base template include markings relating to the age of said woman.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said first portion(s) of said top template includes a corner(s) of said top template.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said second portion(s) of said top template includes an edge(s) of said top template.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said secondary markings on said base template include regions of different colours or shading.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said edge(s) of said top template is/are provided with calibration marks, whereby the fecundability of said woman and/or said couple may be determined by noting the position of said calibration marks relative to said regions of different colours or shading.

According to another aspect of the present invention there is provided a device for assessing human fecundability substantially as described above, wherein said means for assessing the fecundability of said woman and/or said couple includes an indication of the average likelihood of said woman and/or said couple conceiving over a period of time.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said means for assessing the fecundability of said woman and/or said couple includes an indication as to the average likelihood of said woman and/or said couple conceiving after a fertility treatment(s).

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said means for assessing the fecundability of said woman and/or said couple includes an indication as to when said woman and/or said couple should consider opting for a fertility treatment(s) and/or further fertility investigations.

According to another aspect of the present invention there is provided a device for assessing human fecundability, substantially as described above, wherein said device is represented by, or incorporated within, a software program, whereby said device may be viewed and/or used with an electronic device.

According to another aspect of the present invention there is provided a method for assessing human fecundability, said method involving the step of utilising the device, substantially as described above.

It is envisaged that the device (and associated method) may be particularly useful for assessing and/or for illustrating human fecundability, that is, the likelihood of, and/or ability for, a woman (or couple) to conceive over time.

The base template may be of any size, shape, design or configuration as required or as desired.

Preferably the base template may be in the form of a hand held card, which may (for example) be comprised of a substantially rigid and/or inexpensive material such as cardboard (including laminated cardboard) or plastic.

Preferably, the base template may be of a size equal to or less than standard A5-size stationery, so that it may readily and easily be stored (for example, in a draw or folder) and/or carried (for example in a briefcase, diary or handbag). Preferably, the base template may include one or more primary markings representative of at least one fecundability criteria of a woman and/or a couple. However, it is also within the scope of this invention for the one or more primary markings to be representative of at least one fecundability criteria of a man.

Preferably, the primary markings may include markings representative of the age of the woman as this is one of the more important criteria used when assessing the ability for a woman (or couple) to conceive.

Alternatively, or additionally, there may be primary markings representative of other fecundability criteria. Examples include (but are not limited to) the eight possible lifestyle factors which may affect fecundability, which are listed on Page 3 of this specification.

The top template may be of any size, shape, design or configuration as required or as desired, or as dictated by the size, shape and/or configuration of the base template.

Preferably, the top template may include a first portion(s) which may be positioned with respect to the primary markings on the base template.

Preferably, the top template may be movable with respect to the base template, whereby the first portion(s) of the top template may be moved with respect to the primary markings on the base template. For example, the first portion(s) of the top template may include a corners) or a pointers) or cursor(s), and the top template may therefore be moved, or otherwise manipulated, so that the corner(s) or pointer(s) or cursor(s) align with the primary markings on the base template which are appropriate to a particular woman and/or couple.

Preferably, the base template may be substantially (or wholly) circular. In such an embodiment, the primary markings representing the fecundability criteria may be positioned substantially around the periphery of the base template. Preferably the top template may be rotatably fixed to, or mounted upon, the base template, whereby the top template may be rotated about the pivot point in order to align the first portion(s) of the top template with the appropriate primary marking(s) on the base template.

Preferably the top template may be smaller in size and/or area than the base template, whereby portions of the base template are always visible regardless of the orientation or position of the top template. For example, and in one embodiment, if the base template is substantially or wholly circular in nature, then the top template may preferably be substantially hemispherical in nature - whereby it covers only substantially half of the base template at any one time, and regardless of the orientation or positioning of the top template with respect to the base template.

The device may preferably include means for assessing the fecundability of the woman and/or the couple based on the location of a second portion(s) of the top template with respect to secondary markings present on the base template.

For example, the secondary markings present on the base template may be in the form of differently coloured or shaded areas which represent differing assessments (or likelihoods) of fecundability. In such an embodiment, the second portion(s) of the top template may include a calibrated portion(s), and the alignment or meeting of a particular calibrated portion(s) with a particular coloured or shaded area may enable the user to determine the result of a particular fecundability assessment - based on the personal fecundity criteria of the woman and/or the couple.

Preferably, the calibrated portion(s) of the top template may be provided along an edge(s) of the top template.

Alternatively, the secondary markings present on the base template may include calibrated portion(s) and the top template may be provided with differently coloured or shaded areas representing the different assessments (or likelihoods) of fecundability. It may be appreciated that the location and/or configuration of the secondary markings on the base template and/or the location and/or configuration of the first and/or second portion(s) of the top template, allow for useful and accurate information to ultimately be gleaned by users of the device. For this to occur, the configuration of the various markings and/or portion(s) may be dictated by, or based upon, known medical literature and studies pertaining to human fecundability (and/or fertility treatments such as IVF).

The device may be used for assessing any fecundability related matter pertaining to a woman or a couple, as required or as desired.

Preferably however, the device may be used for assessing the average likelihood of the woman and/or said couple conceiving over a period of time.

Preferably the period of time may be in relation to each month of the couple trying to conceive.

Alternatively, or additionally, the device may be used for assessing the average likelihood of the woman and/or the couple conceiving after one fertility treatment, for example after one IVF treatment cycle.

Alternatively, or additionally, the device may be used for assessing when the woman and/or the couple should consider opting for a fertility treatment(s) and/or further fertility investigations.

In one embodiment, the device may also be represented by, or incorporated within, a software program, whereby the device may be viewed and/or used with an electronic device, for example a computer or a mobile device such as a mobile phone, Blackberry ^® or iPhone ^® . In such an embodiment, the features of the device such as the base template and top template may be represented electronically or "virtually' on the screen.

Moreover, movement of the top template may be undertaken or facilitated automatically by the software program once the user has entered the relevant data relating to at least one fecundability criteria of a woman and/or couple.

Alternatively, the user may enter the relevant data by manually moving the electronic representation of the top template with respect to the electronic representation of the bottom template (for example, by clicking on the top template and holding the mouse down to facilitate movement of the top template with respect to the base template by movement of the mouse - or alternatively by movement of a finger on a touch pad).

It is also envisaged that, in such an electronic embodiment, the software for running an electronic version of the device may be able to be downloaded to an electronic device as an apps program.

Alternatively, or additionally, a health professional (or fertility specialist) may have a "virtual" version of the device on their website, and a user accessing the site may be able to use the device by entering the appropriate fecundability criteria in order to obtain an assessment of the user's fecundability.

It is envisaged that the device may serve as a relatively simple and easy-to-use device (and method) which may provide a couple (or health professional) with scientifically robust information regarding a couple's chances of conception, and/or when the couple should seek assistance or intervention regarding conception (both natural and/or via intervention).

PREFERRED EMBODIMENTS

The descriptions preferred forms of the invention to be provided herein, and with reference to the accompanying drawings, are given purely by way of example, and are not to be taken in any way as limiting the scope or extent of the invention.

DRAWINGS

Fig 1 : is a plan view of one possible embodiment of the present invention, Fig 2: is a plan view of the base template illustrated in Fig 1,

Fig 3: is a plan view of the top template illustrated in Fig 1,

Fig 4: is a view of fertility information that may be provided on the reverse side of the base template illustrated in Fig 1, and

Fig 5: is a view of another possible embodiment of the present invention.

DESCRIPTION OF PREFERRED EMBODIMENT

Having regard to Fig 1, there is shown a device for assessing human fecundability, the device being generally indicated by arrow 1. The device 1 includes a base template, generally indicated by arrow 2 and a top template generally indicated by arrow 3.

The base template 2 is circular in shape and includes an upper hemispherical portion 4 and a lower hemispherical portion 5.

The upper hemispherical portion 4 includes primary markings 6 representative of the age of a woman trying to conceive. Likewise, the lower hemispherical portion 5 includes primary markings 7 which are also representative of the age of a woman trying to conceive. For both hemispherical portions 4,5 the age of the woman may be chosen from the range of 25 years of age up to 44 years of age (the Age of 25 is not represented on the base template 2, however it may be appreciated that it lies midway between the Age 44 of the upper hemispherical portion 4 and the Age 26 of the lower hemispherical portion 5).

However, in an alternative embodiment, the age range may begin from a younger age, for example from 18 years upwards - although generally speaking couples are less likely to seek fertility advice until the woman is a least in her mid-twenties (and the average age of birth in New Zealand is currently 30 years - as indicated on the base portion 2 by arrow 8). The base template 2 also includes the useful information that public funding for fertility assistance ends in New Zealand when the woman reaches 40 years of age - as indicated by arrow 9.

Each age represented in each hemisphere 4,5 of the base template 2 is directly opposite its corresponding age in the other hemisphere 4,5. For example, Age 35 in the upper hemispherical portion 4 is 180° opposite the corresponding Age 35 in the lower hemispherical portion 5.

The top template 3 is hemispherical in shape and is rotatably fixed to the base template 2 at the pivot point 10. The top template 3 is able to rotate with respect to the base template 2 about the pivot point 10.

The top template 3 includes an upper potion 11 and a lower portion 12 which share a common edge 13. The top template 3 has an upper corner 14 which serves as a "first portion" (as described previously) of the top template 3, and which may be positioned with respect to the primary markings 6 of the upper portion 4 of the base template 2.

The top template 3 also has a lower corner 15 (which also serves as a "first portion" of the top template 3, (as described previously)), and which may be positioned with respect to the primary markings 7 of the lower portion 5 of the base template 2.

The device 1 includes means for assessing the fecundability of a woman and/or a couple, based on the location of calibration marks on the common edge 13 of the top template 3, with respect to secondary markings on the base template 2. These calibrated markings on the common edge 13 comprise the "second portion(s)" of the top template 3 (as described previously).

The means for assessing human fecundability, utilising the device 1, will now be described in more detail below.

The secondary markings of the upper portion 4 of the base template 2 include a dark blue shaded area 16 which is indicative of the average chance of a fertile couple ordinarily conceiving, per month of trying.

The secondary markings of the upper portion 4 of the base template 2 also include a light blue shaded area 17 which is indicative of the average chance of a fertile couple ordinarily conceiving per cycle of IVF treatment.

The secondary markings of the lower portion 5 of the base template 2 include a green shaded area 18 which is indicative of advice that the couple should continue trying to conceive, except in particular circumstances - with these circumstances being included in the written material 21 on the reverse side 22 of the base template 2 - see Fig 4.

The secondary markings of the lower portion 5 of the base template 2 also include a red shaded area 19 which is indicative of advice that the couple should seek fertility advice or assistance (for example, IVF-type treatments).

The secondary markings of the lower portion 5 of the base template 2 also include an orange shaded area 20 which is indicative of advice that the couple should consider seeing their GP or fertility specialist (the legend for the orange shaded area 20 is not shown in Fig 1, but it is represented in the legend of Fig 5).

The common edge 13 of the upper portion 11 of the top template 3 has calibrated markings, shown as percentages, illustrative of the average chances of the couple ordinarily conceiving per month of trying, both normally and after one cycle of IVF treatment. These percentages range from approximately 0% up to approximately 50%.

Furthermore, the common edge 13 of the lower portion 12 of the top template 3 has calibrated markings, illustrative of the number of months the couple has been trying to conceive. The number of months range from approximately zero months up to approximately 24 months

With reference to Fig 1, a method of use of the device 1 which will illustrate how the device 1 may be used, will now be described in relation to an example where a 35 year old woman has been trying to ordinarily conceive with her partner for six months.

The first step is to align the upper corner 14 and the lower corner 15 of the top template 3 with the Age 35 shown on the upper portion 4 and lower portion 5, respectively, of the base template 2. This is shown in Fig 1.

The percentage chance of the couple ordinarily conceiving per month, is calculated by assessing where the upper calibrated part of the common edge 13 is adjacent the region where the dark blue shaded area 16 meets the light blue shaded area 17 (this region being marked with an "x"). Hence, in the present instance this equates to a percentage of approximately 16%.

Furthermore, the percentage chance of the couple conceiving per cycle of IVF treatment, is calculated by assessing where the upper calibrated part of the common edge 13 is adjacent the region where the light blue shaded area 17 ends (this region also being marked with an "x"). Hence, in the present instance this equates to a percentage of approximately 40%.

Moreover, information as to whether the couple should keep trying to conceive normally, or possibly consider seeking professional advice or fertility assistance, is provided by where the lower calibrated part of the common edge 13 meets the secondary markings of the lower portion 5 of the base template 2.

That is, as the couple has been trying for six months, the calibrated part of the common edge 13 which represents six months, falls in the green shaded area 18 (marked with an "x"). This is indicative of a recommendation that the couple keep on trying (except under special circumstances, as referred to previously - and which are outlined in the written material 21 on the reverse side 22 of the base template 2 - see Fig 4).

If the same couple had been trying for 18 months, it can be seen that this places them in the red shaded area 19, and hence the couple are recommended to take further action (for example, by seeking professional advice and/or fertility assistance).

Fig 2 illustrates the base template 2 in its entirety, and illustrates the overall configuration of the primary and secondary markings. The shape, design and configuration of the primary and secondary markings are based upon known medical literature pertaining to human fecundability (and/or fertility treatments such as IVF). Such literature will be well known to those skilled in the art.

For example, the configuration of the secondary markings 16,17 of the upper portion 4 of the base template 2 (with respect to the calibrated edge of the common edge 13) in relation to pregnancy rates by age are based on well known medical literature relating to pregnancy rates by age.

The configuration of the secondary markings 16,17 of the upper portion 4 of the base template 2 (with respect to the calibrated edge of the common edge 13) in relation to success rates by age for IVF, is based on The Australia and New Zealand Assisted Reproduction Database (ANZARD) which was implemented in 2004.

The configuration of the secondary markings 18,19,20 of the lower portion 5 of the base template 2 (with respect to the calibrated edge of the common edge 13) are based on well known medical literature and studies.

For example, it is well established that at 25 years of age if you haven't conceived within six cycles, then there may be an issue, and so a referral is recommended. Hence, this acts as the six month guideline (ie, the region between the green area 18 and the orange area 20 at Age 25)

Furthermore, 30 years is the median age of child bearing in NZ, and this therefore acts as the twelve month guideline (ie, the region between the green area 18 and orange area 20 at Age 30).

The average age of conception for a 35 year old woman, based on data collected at North Shore Hospital, New Zealand, is 15 months, and this therefore acts as the 15 month guideline (ie, the region between the orange area 20 and the red area 19 at Age 35).

A further example of literature in this field which may be utilised to assess the shape and configuration of the markings on the base template 2 and top template 3 is Human Reproduction. 18(9): 1959- 1966, September 2003, Gnoth, C. 1,4; Godehardt, D. 1; Godehardt, E. 2; Frank-Herrmann, P. 1,3; Freundl, G. 1

As such, the information provided by use of the device 1 is both scientifically based and scientifically robust.

Fig 3 illustrates the top template 2 on its own, and Fig 4 illustrates an example of possible fertility information 21 which may be included on the reverse side 22 of the base template

2.

Fig 5 illustrates an embodiment of the invention where the device 1 is represented by, or incorporated within, a software program, whereby the device 1 may be viewed and/or used with an electronic device.

The embodiment illustrated in Fig 5 may therefore be a "virtual" (or "paper-less") version of the device 1, for example, one being hosted on the website or computer or mobile electronic device of a user or health professional. A user accessing the site or program may be able to use the device 1 by entering the appropriate fecundability criteria in order to obtain the assessment of the user's fecundability. For convenience and ease of viewing, the illustration in Fig 5 does not have numbered arrows corresponding to the various features or components of the device 1 — as these have been illustrated previously with respect to Figs 1-3.

For example, and with reference to the embodiment shown in Fig 5, a method of use of the device 1 which will illustrate how it may be used, will now be described in relation to an example where a 32 year old woman has been trying to ordinarily conceive with her partner for 14 months. The user enters the woman's age of 32 by using their computer mouse to slide the "Age" cursor 24 to the position as shown. The user also uses their computer mouse to slide the "Months Trying" cursor 25 to the position as shown.

The user can then read the results of their enquiry directly off the device 1 - as described previously in relation to the embodiment shown in Fig 1. In the embodiment shown, the top template 3 is adapted to move automatically to the position as shown in Fig 5, once the relevant data (age 32 and 14 months trying to conceive) has been entered by the user.

However, the "virtual" version as shown in Fig 5 also calculates the relevant results and displays these on the device 1. That is, it can be seen that the woman has a 20% chance per month of conceiving normally, and a 46% chance of conceiving after one IVF treatment cycle.

Furthermore, because 14 months of trying places the couple in the "orange zone", the couple are recommended to start thinking about seeing their GP or fertility specialist. To assist in viewing this result, there is provided an electronic cursor 26, which automatically moves to the relevant position, based on the criteria entered by the user.

It is envisaged that the invention may be suitable for use by couples and professionals alike.

It is also envisaged that the invention may be used for assessing the fecundability of non- humans such as other mammals, based on established fecundability criteria for any one species.

Some advantages of the invention include (but are not limited to) the following:

1. The device 1 is simple and easy to use.

2. The device 1 is relatively inexpensive to produce. 3. The device 1 may be used in relation to a variety of differing criteria and personal circumstances, and hence a couple may continue referring to the device as their personal circumstances change and/or after different times of trying to conceive.

4. The device is primarily visual which offers simplicity of use and/or ease of understanding of the results.

5. The device 1 can help couples address or overcome procrastination in seeking help, especially before it is too late to do so.

6. Notwithstanding its simplicity, the device 1 offers scientifically robust information.

7. The device 1 offers consistent information to people using it.

8. The device is 1 educational and serves to raise people's awareness of fertility issues generally.

9. The device 1 may be used with mobile electronic devices such as mobile phones, and may therefore readily be accessible or usable by anyone at anytime.

VARIATIONS

While the embodiments described above are currently preferred, it will be appreciated that a wide range of other variations might also be made within the general spirit and scope of the invention and/or as defined by the appended claims.