This week, almost eight years since home sperm-testing in the UK was first launched and made available in Boots, a second product to assess male fertility hit the shelves. Apart from the fact that the media seem to have forgotten the earlier 'first', what else has changed during this time?
The previous test, Fertell, which I had a hand in the scientific design of, was designed to mimic the selection of sperm by the human cervix. In the words of Dr Allan Pacey, now chair of the British Fertility Society (see BioNews 340), the kit was 'a neat device which actually examines how well sperm perform under "test conditions" rather than just counting them and seeing how well they move'.
Fertell is no longer produced but, both before and since, a number of tests promising similar home-diagnosis of male fertility have been advertised and marketed over the internet. As high-street pharmacies re-enter this market a key question may be not 'what is the demand?', but 'what is being demanded?'
Around the world couples are advised to try for a child for a period of time before seeking diagnosis of a problem. For many having reliable information at an early stage may be an advantage, certainly if the woman is older. It is vital that couples have information they can rely on, which brings us to the question of what, exactly, in the case of home sperm tests is being tested.
The product that hit the shelves this week claims accurate determination of whether a man has more or less than 20 million sperm per millilitre (1). Unlike Fertell, it makes no assessment of whether the sperm are alive or dead; whether they can swim; or any number of other parameters which would be assessed in a standard laboratory semen analysis as recommended by the World Health Organisation (WHO) and the UK's learned societies.
An implication of calling something SpermCheck Fertility - with a definitive-sounding 'low' or 'normal' result and a quoted accuracy over 98 percent is that many couples would rely on this as a fertility diagnostic.
In fact, the test assesses just one of the many possible male fertility stumbling blocks. Just having a certain number of sperm is not enough normal sperm shape and motility are also vital factors for fertility. In addition, the test employs a threshold higher than that recommended by the WHO. Since 2010 laboratories worldwide have adopted the revised WHO guidance of recognising 15 million sperm per millilitre rather than 20 as the lower reference limit for a normal sperm count (2).
Discussion in the news has focused on worries around how ethical it may be to leave couples burdened at home with finding out something is 'wrong'. Perhaps the greater worry should be that they may be assigning blame to one partner or the other based on what at best is not a full diagnosis and may be a total misdiagnosis. In this situation, continuing to try as a woman gets older will lessen the chances of having future success with fertility treatment.
In 2006 Allan Pacey said that men using a home test should remember that 'one failed test isn't necessarily going to doom you to male infertility for the rest of your life'. With this in mind, perhaps we should encourage the availability of laboratory semen analysis to any that require it. If you want to know something about your fertility you really need a robust result, one as complete as possible, with the relevant clinical support. Until home sperm testing reaches that standard, greater availability of accurate clinical laboratory tests must be the goal.