Researchers received Food and Drug Administration approval today for a 90-man study of the Intra Vas Device (IVD), a nonhormonal contraceptive that stops sperm in their tracks. The study, to take place in Seattle, Washington and St. Paul, Minnesota, will bring men one step closer to having their first new contraceptive in more than a century.

"Preliminary studies in animals and men show that this doesn't have the side effects of hormonal methods," said Jim Stice, president of Shepherd Medical Company, a consortium of researchers and entrepreneurs developing the device. "The concept is pretty simple: A set of tiny plugs block sperm as they travel through a tube called the vas deferens. Men don't need to worry that they'll have acne or gain weight or have their sex drive go up or down--all things that can happen when you manipulate hormones."

This will be the second contraceptive study of the IVD in men. In the pilot study, the method was very effective: All 30 men either had no sperm in their semen or had levels too low to cause a pregnancy. Early monkey studies showed reversibility after seven months of use, but reversibility studies in men have thus far only tested same-day insertion and removal.

Elaine Lissner, director of the nonprofit Male Contraception Information Project, is cautiously optimistic. "The Holy Grail of contraception is a long-term, reversible method without any hormonal side effects," she said. "Right now the IVD developers can't guarantee that it's reversible in men like it has been in animals, so they're billing it as a kinder, gentler vasectomy. But if it turns out to be reversible, they're going to have a line out the door."

Demand from Men

The concept of blocking sperm in the vas deferens is not new: each year about
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5-May-2006