Washington Post
12 November 2002

A Fertility Test -- For Him
Home Kit Evaluates a Man's Contribution

By Jennifer Huget

For about 40 bucks, a man can now check his sperm density in the privacy of his own home. But whether that's money well spent is debatable.

The FertilMARQ in-home male fertility test, approved in 2001 by the Food and Drug Administration, allows men to assess the concentration of their sperm, one of several variables known to affect male fertility.

Sold via the Internet and locally at only some drugstores, FertilMARQ will soon be the focus of a national marketing campaign and will then be more widely available at pharmacies and mass-merchandise chain stores. The kit takes its place among the in-home pregnancy tests and ovulation predictor kits that have for years been bolstering women's efforts to conceive.

By its mere presence, FertilMARQ, devised by former Harvard Medical School professor Juan Alvarez and marketed in the United States under the brand name Baby Start by Lake Consumer Products, evens the playing field a bit. While approximately 40 percent of the time the fertility problems that are estimated to plague more than 2 million couples in the United States stem from the male side of the equation -- roughly the same percentage attributed to female reproductive problems -- the over-the-counter approach to infertility has until now focused entirely on female chemistry. (Problems are found in both parties about 10 percent of the time, no explanation is found for the final 10 percent.)

FertilMARQ -- each kit contains materials for two separate tests -- has men empty a spermicide-free condom into a cup coated with a material that speeds the process by which semen turns from viscous to liquid. After 15 minutes, the man places a drop of the liquefied semen in a well on the plastic test cassette -- which looks a lot like a home pregnancy test strip -- adds a bit of blue solution and then some clear solution and waits. If, after five minutes, the sample in the test well turns a darker blue than the reference blue shown on the test cassette, the result is positive, meaning sperm concentration tops the 20 million sperm per milliliter of ejaculate the World Health Organization says is required for fertility. A blue lighter than the reference blue is a negative result, indicating sperm concentration below that mark.

The whole thing (the chemistry, that is) takes about 30 minutes. Tests offered as part of the FDA approval process showed the FertilMARQ test matching professional test results 87 percent of the time, with home testers getting the same results as pros 141 out of 158 times when the FertilMARQ results were positive and 27 out of 36 times for negatives, according to Lake Consumer Products.

Now that men have equal opportunity to analyze their own bodily fluids, though, the question remains: Once a guy knows whether his sperm concentration makes the grade, what's he going to do about it?

One Measure Among Many

Maybe draw the wrong conclusion, says a skeptical Robert Stillman, a reproductive endocrinologist at Shady Grove Fertility Reproductive Science Center in Rockville. Says Stillman, "Some information is good. Too little information can be misleading."

The problem with FertilMARQ, he says, is that it doesn't tell users about any of the other factors affecting fertility, from pH and white blood cell count to speed and motility (a measure of the sperm cells' ability to swim toward the egg). Nor does it provide information about the sperm cells' morphology (size and shape). This last component, Stillman explains, is the single most important thing to know about a man's sperm in evaluating his capacity to conceive.

"If the test is applied appropriately -- and that may take some Mr. Wizard work at home that not all consumers would be comfortable with -- and if an abnormal result leads to earlier evaluation [by a physician], I'm all for that," Stillman says. "But if the test is used in lieu of consultation with a physician, it's . . . harmful, especially if it reassures when it shouldn't."

Once the reason for a man's infertility is determined, Stillman says, a physician can determine an appropriate treatment approach, which may range from a test-tube procedure called sperm-washing and intrauterine insemination to removal of varicose veins in the scrotum. Delaying evaluation and treatment only delays potential conception, he adds.

Noting that his clinic finds at-home ovulation predictor kits and pregnancy tests "very accurate, very helpful," Stillman adds that "we're not opposed to home testing. It needs to be evaluated test by test."

But because the FertilMARQ test offers such limited information, Stillman wonders whether it's much of a bargain. A professional semen analysis can be had at a physician's office for as little as $40, Stillman says, though more detailed testing looking at 10 or 15 components can cost up to $100. Some of those costs, however, may be covered by health insurance; as an over-the-counter product, FertilMARQ isn't a likely candidate for coverage.

For the price of the at-home test, Stillman says, "I'd rather see a sign above the shelf that says, 'Infertility is 40 percent male factor. See a doctor.' I would rather collect all that money and do a PR campaign" spreading that message, he says.

Privacy and Pre-Nups

Eric Dorman, president of Embryotech, the Massachusetts company that developed Alvarez's technology into an at-home test, defends the product, despite its limitations.

"FertilMARQ is not a diagnostic tool -- it's an initial screen," Dorman says. Responding to what he describes as doctors' fears that the product will "take some of their business away," he says that is not the intent. Just as doctors routinely administer in-office pregnancy tests to confirm at-home test results, he says, he expects the same system to prevail with the male counterpart.

"We're trying to drive people to the physicians," Dorman says, noting that the kit's instructions urge people to consider the test "preliminary" and include a reporting form for sharing results with a doctor. "Doing it at home is an initial step in looking at 'male factor' as an issue" in infertility, he says.

One of the test's prime virtues, Dorman notes, is the "privacy thing. It's tough for a guy to think about going into a room in a clinic with people waiting, and having to hand the cup outside the door," Dorman says. At the very least, he adds, taking such a test at home may serve as a trial run, getting guys comfortable with producing on demand and emptying into a cup should they need to do it again at a doctor's office.

Dorman says his company is hard at work on a test for sperm motility, but that morphology analysis is likely to remain solely in physicians' hands. "I don't believe that you'll ever have a home test kit that will grade morphology," he says. "You would have to actually see the sperm. That's bigger than we can handle."

In the meantime, Dorman says he expects FertilMARQ's major consumers to be women buying it on their partners' behalf, to get men involved in finding the cause of the couple's inability to conceive. The idea might be to get them to shoulder their share of the responsibility or, in a kinder vein, to remove some of the stigma attached to male infertility. "I don't think sperm count has anything to do with masculinity," says Dorman, "but I think some men think it does."

Beyond its use by couples trying to conceive, he adds, "I think a small percentage of the market will be guys who are just curious."

Stillman agrees that the product's biggest market will be women, but has a different take on how they'll put it to use. "I can see a lot of women using it surreptitiously" to check their partners' sperm concentration, Stillman says. "Kind of like a pre-nup," he adds.

This prospect appears to dumbfound Dorman. "I never heard that," he says. "I don't know how to respond." After a moment, though, he adds, "If a woman's going to do that, you might want to think twice about marrying her."

Jennifer Huget is a regular contributor to the Health section.