Over-the-counter fertility testing Print E-mail
Written by Robert D Barlow, Med-Direct International Ltd   
The first new-style over-the-counter (OTC) home fertility testing products are entering the market and several factors suggest that this market should be lucrative.

Most women are leaving childbearing until their 30s and they are aware that in vitro fertilisation (IVF) techniques have limited success, are expensive, invasive, subject to waiting lists and the postcode lottery of NHS supply.

What is less well-publicised is that a failure to conceive within a few months leads couples to become anxious and turn to the medical profession for support, only to find that they have to wait for at least one year before investigations will start. It is this vacuum that a variety of new diagnostic tests grouped under the “home fertility test” banner aim to fill.

What is a fertility test?


It is important to recognise that there is actually no such thing as a fertility test in the sense that no diagnostic test can reliably identify whether a man, woman or couple are fertile. This can only be proved with the arrival of a pregnancy.

This lack of diagnostic accuracy is reflected in the observation that around 20 per cent of infertile couples are subsequently diagnosed with idiopathic infertility. Nonetheless doctors still use a battery of diagnostic tests that are usually based on semen analysis of the man and hormonal tests of the woman, and the new developments in home fertility tests follow the same approach.

Men's fertility test


The popular perception that infertility is largely a woman’s problem remains when, in fact, 40 per cent of problems can be attributed to the man. The arrival of OTC tests for male fertility offer an opportunity to correct this false perception and takes account of men’s general reluctance to participate in fertility issues. There are a number of cultural reasons for this reluctance but a home test can at least be performed discreetly and privately, thereby removing a major obstacle to male involvement.

At time of writing (summer 2006) there are just two tests for male factor infertility available OTC but others are being developed. One product allows men to evaluate two separate semen samples in the privacy of their home. It takes 15 minutes and costs £29.99. The test is simple to perform and is based on sperm being trapped on a semi-permeable membrane before having the DNA in the sperm head stained blue with a thiazine dye. The degree of colour change is then compared with a reference colour, which allows the man to determine whether he meets the minimum fertility requirement established by the World Health Organization (WHO) of a total 20 million sperm per millilitre of ejaculate. Clinical trials have shown a 97 per cent diagnostic accuracy when compared with laboratory-based semen analysis.  

Another test, introduced to the UK market in January 2006 through Boots only, allows a single test on a semen sample and gives results in 80 minutes. It must be purchased with the female test (see below) with a combined cost of £79.99. The test is performed in a device that allows motile sperm to swim through a channel mimicking cervical mucus, and subsequently to be measured in an antibody reaction on a test strip. By comparing the test result with a reference line the man can determine whether he has more or less than the WHO minimum fertility requirement of 10 million motile sperm per millilitre of ejaculate. The manufacturers claim 95 per cent accuracy.

Women's fertility test


The measurement of follicle-simulating hormone (FSH) in blood or urine is widely used to assess whether a woman is likely to respond to IVF treatment or not. As women enter their 30s, the number of eggs remaining in their ovaries declines and FSH levels begin to rise. High FSH levels have therefore become recognised as a simple measure of ovarian reserve i.e. how many eggs remain in the ovaries. The measurement of urine FSH is easily accomplished using antibody technology identical to existing methods for ovulation and pregnancy tests. Results can be obtained in a few minutes and the new home fertility tests for women use this approach.

However, this method of testing needs to take account of the fact that FSH levels vary dramatically during the menstrual cycle. One approach is to adopt a two-test strategy (costing £9.99), where a woman takes the first test at any time of her menstrual cycle and then again 7–10 days later. A positive result is given when FSH levels are above 25miu/ml. Two positive results indicate the progress of the woman’s ‘biological clock’ to a point where her ovarian reserve is likely to be reduced.

An alternative approach is to test on day three of the menstrual cycle and use a cut-off level of 10miu/ml as a mimic of the three-day blood test commonly performed in fertility centres. A product using this latter approach is sold in conjunction with the male test mentioned above (at a cost of £79.99).

Women who have negative test results by either strategy, with regular menstrual cycles, are given the ‘all clear’ to continue trying for a pregnancy. Those with positive test results are advised to consult their doctor for further investigation.

Accuracy


While these tests for men and women do help fill a vacuum for consumers and therefore represent a significant step forward, they suffer from the simple fact that 100 per cent diagnostic accuracy is not possible. In practice the tests will produce a few false positive and false negative results. Nonetheless those coming up with results indicating an increased risk of infertility are likely to benefit from early consultation.

Timing


Only in the last decade has it become apparent that women are at their most fertile just before ovulation and one recognised cause of a failure to conceive is simply that couples do not have intercourse at the right time. Ovulation prediction methods therefore come under the OTC “fertility test” banner. Several products are available including urine-based luteinising hormone (LH) tests, mini-microscopes detecting changes in saliva and a variety of electronic devices measuring some physiological change that occurs in women around the time of ovulation.

The urine-based LH tests are the most popular and are virtually 100 per cent reliable. Costs range from £10–20 and manufacturers provide either five or seven tests in a pack, sufficient for one month.

However, it should be noted that the use of digital thermometers and temperature charting should not be recommended for women trying to conceive, even though often still recommended by health practitioners. The main reason is that the temperature rise occurring at the time of ovulation is simply past women’s most fertile time.

A word about pregnancy tests


The recent introduction of ultra-sensitive tests has created a hitherto unseen problem, which deserves a mention here. Research has clearly shown that many women suffer from early loss of the embryo. This loss occurs after conception is confirmed and is due to factors including implantation failure or nature’s way of removing genetic abnormalities.

However, the very sensitive pregnancy tests (<25 miu/ml human chorionic gonadotropin [HCG]) can detect pregnancy as early as 7–10 days after conception and, while this may be great news for the woman who goes on to a normal pregnancy, it can be devastating to a woman who sees a positive test which then disappears and a menstrual bleed occurs. Often the pregnancy test is blamed for the ‘false’ positive result when actually an early abortion may have been the cause.

Conclusion


With at least one in six couples experiencing difficulty in conceiving it is not difficult to recognise that a large market exists for OTC products that can screen for fertility, help identify fertile days and confirm pregnancy. The availability of OTC products for men and women offers a new market opportunity to pharmacists who can offer these products and support for couples planning a pregnancy.

These OTC products are sufficiently accurate, and comparable to existing medical testing strategies, to ensure that any medical practitioner will understand a problem result when subsequently approached by the consumer. The pharmacist has a key role to play in the promotion of these new products in order to meet the measurable human need and tap the commercial possibilities.
 
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