ContraVac SpermCheck Male Fertility Tests Available in Stores

By Timothy W. Martin

Even when couples are grappling with infertility, many men balk at getting their sperm count checked. Now, an over-the-counter product enables them to check their count without a trip to the doctor.

SpermCheck Fertility promises to spot potential problems with male fertility in just about 10 minutes, potentially avoiding unneeded visits by women to the gynecologist or obstetrician, according to its owner and distributor, ContraVac Inc., a biotechnology start-up in Charlottesville, Va.

The company says it offers men the same kind of quick test women have access to with pregnancy or ovulation tests. “There’s now some gender equality on the family planning shelf,” said John C. Herr, a University of Virginia cell biology professor who came up with the product’s concept and helped in its development with a team of university staff.

More than seven million couples report having infertility issues every year, according to the Centers for Disease Control and Prevention. And about one-third of infertility cases are the result of male issues, with another third female, according to the agency. (The remaining third of infertility cases are caused by a combination of male and female problems or are unknown.)

Family planning products are a $250 million industry, dominated for now by ovulation-prediction and pregnancy-test kits, according to SymphonyIRI Group, a Chicago-based market-research firm.

After winning approval from the Food and Drug Administration, ContraVacbegan selling the kits in recent months online, through the websites of drug chains Walgreen Co. and CVS Caremark Corp. Walgreen plans to sell SpermCheck at its stores for $39.99 starting in mid-April.

ContraVac says the tests are 98% accurate, based on independent tests that were submitted to the FDA. Still, urologists caution that SpermCheck only measures one potential cause of male fertility. Sperm count “is just one of several parameters that’s looked at when we look at male fertility,” said Arthur Tarantino, president of the American Association of Clinical Urologists, adding male infertility could also occur due to the sperm’s movement or shape.

And while SpermCheck was FDA-approved to identify any sperm count lower than 20 million sperm per milliliter, the World Health Organization recently revised its standard, identifying any sperm count lower than 15 million sperm per milliliter as low. Most men, however, are capable of producing up to 300 million sperm per milliliter, so the lowered standard is “statistically extremely small,” Mr. Herr said.

Most semen analysis conducted by doctors costs between $100 and $250, though most health plans cover the test, according to urologists.

SpermCheck works by taking a semen sample and adding a solution that extracts “SP-10” protein found only in the coating of the sperm’s head. The concentration of the protein is proportional to a man’s sperm level. Within seven minutes, a line appears on the test kit if the sperm level is normal—not unlike a pregnancy test.

ContraVac Chief Executive Ray Lopez expects women—not men—to be the main purchasers of the product at stores. “She’s in there anyway, looking at the pregnancy test, wondering: ‘Hmm, why don’t I spend $40 and see if my man’s got an issue,’ ” Mr. Lopez said.

David Denison, a 30-year-old project manager from Greensboro, N.C., had been reluctant to get tested at a doctor’s office, so he bought SpermCheck online.

“The nice thing about this is that nobody knows you’re doing it,” said Mr. Denison, who said he would not feel awkward buying the test at a drugstore. The at-home product also allowed him flexibility in his schedule.

Source: http://online.wsj.com/article/SB10001424052702304450004577277732780865786.html