NEW YORK (Reuters Health) - Many at-home kits used to predict a baby's gender, a woman's future fertility, or a man's sperm viability lack solid, independent data confirming their accuracy, according to a new review of fertility and pregnancy tests.
A trio of researchers from Johns Hopkins Medical Institutions in Baltimore looked at dozens of products across a range of applications, including pregnancy tests, genetic screens, and various measurements used to predict when a woman is ovulating.
"A lot of them are good and serve a useful purpose," Dr. Paul Brezina, one of the study authors, told Reuters Health, "but some are not, and may even have claims that are misleading to patients."
The researchers looked through a database of medical journals, searched online, and spoke with manufacturers to assess the quality of evidence available for each product. They published their results this month in the medical journal Fertility and Sterility.
Common, over-the-counter pregnancy tests that measure a hormone in a woman's urine are some of the more reliable products available, Brezina and his colleagues found. Pregnancy tests "have been subjected to the scrutiny of scientific investigation and have publicly mandated quality control measures aimed at ensuring their accuracy," the authors write.
The same could be said for fertility monitors that use hormone concentrations to predict when a woman is ovulating. These include the ClearPlan Easy Ovulation Test Pack, First Response, Answer Quick, and Simple One Step Ovulation.
But the positive reviews pretty much stop there.
A variety of other consumer products used to predict a woman's ovulation -- such as tests that analyze saliva or vaginal secretions -- failed to have reliable, independent studies confirming their accuracy, for instance.
And the same deficiencies mar products to identify a baby's sex, such as the Intelligender Prediction Test and the Best Baby Gender Test.
"We looked hard, and we couldn't find any data," Brezina said.
Rebecca Griffin, the co-founder of Intelligender, told Reuters Health that independent groups in Australia and Mexico have tested the accuracy of her product, but their results have not been published yet. She said Intelligender's website will post the results in the future.
Regardless, her company doesn't market its baby sex predictor based on accuracy.
"I wouldn't want anyone to buy our test assuming 100 percent accuracy," she said. Rather, the test is intended to be a fun way to "bridge the curiosity gap," and should not replace a doctor's assessment.
Manufacturers of the Clear Blue Easy and First Response pregnancy and fertility tests did not respond immediately to a request for comment.
In some cases, a lack of accuracy could be harmful, said Dr. Jackie Gutmann, a fertility specialist at Reproductive Medicine Associates of Philadelphia, who was not involved in the new review.
"The bigger concern with some of these tests is being falsely reassured, because (people who use the tests) won't seek adequate care quickly enough," Gutmann told Reuters Health.
For instance, Gutmann points out, at-home tests for FSH -- a hormone that rises as a woman's egg supply runs low, and is used to predict menopause -- can give a false sense of security if the test is inaccurate.
Brezina and his colleagues were unable to determine the threshold level of hormone these products detect, and therefore, whether their sensitivity is adequate.
Cost was also a factor the authors included in their review. For example, electronic temperature monitors, which help detect ovulation, can cost hundreds of dollars, but consumers could also monitor ovulation cheaply with a calendar and a thermometer.
In total, Brezina said, would-be parents spend a billion dollars annually on at-home fertility and pregnancy products.
Nearly one in six couples in the US has trouble conceiving a baby, and about half the time the problem is with the man, according to the American Urological Association.
"I think at-home testing will become more and more of a tool" used by parents and physicians, Brezina said. "I would encourage people to have a discussion with their doctor about what are the tests that are really worth doing."
Brezina said he and his colleagues received no funding for this study, except for their salaries at Johns Hopkins.
SOURCE: http://bit.ly/gqExAw Fertility and Sterility, online February 16, 2011.
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