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
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.
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.
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.)
-- 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.
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.
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?
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."
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.
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."
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.
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."
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.
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.
Eric Dorman, president of Embryotech, the Massachusetts company
that developed Alvarez's technology into an at-home test, defends
the product, despite its limitations.
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.
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.
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.
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."
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."
its use by couples trying to conceive, he adds, "I think a
small percentage of the market will be guys who are just curious."
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,"
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."
Huget is a regular contributor to the Health section.