A 鈥渉is and hers鈥� home fertility test kit has been developed by a UK team. The company behind the project hopes that couples trying to conceive could use the kit as an early indicator of any biological problems. But it has been widely criticised by fertility experts.
Fertell contains two tests. The first measures the active concentration of sperm in a semen sample, while the second measures a key hormone associated with fertility in women.
Christopher Barratt at Birmingham University, UK, led the development of the sperm test. 鈥淭he current screen for infertility is to try for 12 months and then seek medical advice,鈥� he says. 鈥淏ut 40 per cent of all cases of infertility are due to male factors, and this test can indicate early on if there is potentially a problem with the man that indicates the couple should seek advice.鈥�
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But Simon Fishel of the Park Hospital in Nottingham dismisses the test as 鈥渁 gimmick. There are lots of variants that need to be considered when looking an infertile couple,鈥� he says. 鈥淎nd what kind of advice are the couples going to get? I don鈥檛 think it really offers much in the way of self help 鈥� if anything, it would probably create more anxiety.鈥�
Geoffrey Trew of the IVF unit at Hammersmith Hospital in London agrees. 鈥淭he biggest problem with all home test kits is reliability. A false 鈥渘ormal鈥� result could artificially reassure people and delay their getting help 鈥� and with female fertility in particular, time is everything.鈥�
Hormonal activity
London-based company Genosis has funded the kit鈥檚 development. If large scale clinical trials go well, it will be on sale early in 2002. But it has not yet fixed a price tag.
The female test is based on a standard lab urine test for follicle stimulating hormone. High levels of this hormone indicate that there are relatively few immature eggs in the ovary.
Women undergoing fertility tests in a clinic receive a physical examination as well as chemical tests. 鈥淥bviously, this test wouldn鈥檛 pick up blocked fallopian tubes, for example,鈥� says Paul Bateman of Genosis. 鈥淏ut most female infertility is associated with ovarian problems 鈥� and high levels of FSH are a common indicator of these types of problem.鈥�
Test run
Lab tests for male fertility involve examining a sperm sample using a microscope. 鈥淥ur test mimics the transport of sperm in the female reproductive tract,鈥� says Barratt.
After depositing semen in a container, a man would press a button to trigger the release of a column of artificial cervical mucus. This is then automatically heated to body temperature. Only 鈥渘ormal鈥� sperm are able to swim up through the column, to be collected and tagged using antibodies.
If the sample has more than 10 million motile (active) sperm per millilitres (equivalent to the World Health Organization guidelines for 鈥渘ormality鈥�) a red line will appear.
The male test, which takes 30 minutes, will pick up 鈥渢he huge majority of male problems,鈥� Barratt says.
鈥淥ne third of male patients attending our clinic don鈥檛 turn up for semen analysis because of embarrassment,鈥� he adds. 鈥淭his will allow them to do it in the comfort of their own home.鈥�
What鈥檚 normal?
Picking up problems early on 鈥� particularly in the woman 鈥� could make fertility treatments more likely to succeed, Barratt says.
But, says Trew: 鈥淔or FSH levels, for example, there is a lot of disagreement about what is normal. And even if a woman did have a normal result, it doesn鈥檛 mean she鈥檚 fertile.鈥�
Bateman says the company will provide detailed information with the kits, explaining what an 鈥渁bnormal鈥� result means. It will also set up a free telephone number that couples can call for advice, he says.
But Fishel says that couples having difficulty conceiving and using the kit will still need to see a doctor, whatever the results of the test.
Barratt presented his research at the annual conference of the European Society of Human Reproduction and Embryology in Lausanne, Switzerland.