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CanWest News Service , February 24, 2005

Birth control for men promising

Author : Bruce Ward

OTTAWA - It's called an IVD, and by the end of the decade it may be to male birth control what the iPod is to music geeks.

The Intra Vas Device has the potential to bring about a societal shift by transferring the responsibility for birth control from women to men.

The IVD -- the world's first implantable male contraceptive -- is being billed as a reversible alternative to permanent vasectomy and is anticipated to provide contraceptive effectiveness comparable to the IUD and the birth control pill.

The IVD works something like a vasectomy, only better, explains Dr. Neil Pollock, Vancouver's top vasectomy surgeon and a partner in Shepherd Medical, the U.S. company that owns the patents for the IVD.

"The big bonus that we are anticipating this device will have is the reversibility. Whereas with vasectomy, it's a complex three to four-hour microsurgery, expensive, and with limited success rates."

The IVD -- a 2.5-centimetre hollow silicone plug -- is implanted into the vas deferens tubes to block the flow of sperm from the testicles to the penis.

Implanting the IVD involves accessing the vas deferens tubes, much like a vasectomy. But rather than cutting and cauterizing the tubes, which permanently damages them, only a small opening is made in each tube. The tubes are then capped with silicone plugs. The seven-minute procedure is carried out under local anesthetic in a doctor's office.

The IVD can later be removed in a procedure similar to its insertion, thereby re-establishing sperm flow.

Although men are a tough sell when it comes to contraceptives, the device could revolutionize the multibillion- dollar birth control industry.

Shepherd Medical has been given a $1.4-million grant from the U.S. National Institutes of Health for clinical trials on humans. The clinical study is expected to begin this year, pending Food and Drug Administration (FDA) investigational device exemption approval.

"This study is going to see us leave the device in 90 men in two centres in Seattle, and then we're going to follow these men for 18 months. We're going to assess the contraceptive efficacy, how the device works. We're going to compare side-effects to vasectomy and test the device for side-effects and complications. And that's going to be under FDA approved conditions."

The Seattle trials are "a big step forward" for the IVD, added Dr. Pollock. "We're hoping that this data might be strong enough for consideration for approval in Europe. And then we might need another study for approval in the U.S. and Canada. So our timeline is to have approval in Europe, and then the U.S. and Canada by the end of the decade."

Men are known to be wusses about pain, and squeamish when it to comes to their reproductive bits. Which is why Dr. Pollock has developed no-needle, no-scalpel vasectomy procedures at his five clinics.

To allay their anxieties, guys get to listen to their own CDs during the vasectomy procedure, and they can even leave their shoes and socks on.

But that's the vasectomy. To implant an IVD, the surgeon makes a tiny hole in the scrotal sac using an inserter tool. In diagrams, this tool looks something like a miniature K-Tel Fishin' Magician. Then the IVD is implanted through the opening into the tubes. Silicone caps are then plugged into each tube, blocking the sperm.

So far, the IVD has successfully completed two separate primate studies and preliminary human trials.

"We're hoping human studies about reversibility of IVDs will support what the primate studies supported," said Dr. Pollock.

"The device was fully reversible in primates. So if that's the case, basically you've got a reversible implant contraceptive device that would be great as an option for guys in a relationship who have no kids, or who are in between kids, or who are finished with their families."

But every prospective user will have to decide whether the IVD is right for him.

"It's a matter of each person or couple weighing out every contraceptive option -- the side-effects and profile -- and how it fits in with their priorities and lifestyle choices."

<< CanWest News Service -- 2/24/05 >>

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