Health Canada has given approval for the first human clinical trials for a new male contraceptive device that is believed to be as effective as a vasectomy but that is completely reversible.
The contraceptive is called the Intra Vas Device. It's made up of two tiny, flexible and hollow silicon plugs, each about one millimetre in diameter and one-and-a-half centimetres long.
Two plugs are inserted through the scrotum into each testicle and into the vas deferens tubes, which carry sperm from the testicles to the penis.
The tubes don't block the production of semen, which is 90 per cent ejaculatory fluid, but do block the 10 per cent of semen that is made of sperm. The blocked sperm are simply reabsorbed by the body. And any sperm that make it past the first plug are stopped by the second.
The 20-minute procedure differs from a vasectomy, a surgical procedure in which the vas deferens tubes are actually cut. Vasectomies can be reversed in some instances by a skilled microsurgeon but are often unsuccessful.
With the Intra Vas, the devices do not damage the vas deferns tubes and can be removed and re-inserted easily and perhaps repeatedly. Initial studies suggest the devices don't interfere with libido, sensation, ability to have erections or to ejaculate.
Dr. Neil Pollock, a Vancouver physician who is a prominent expert on vasectomies will lead the initial trials of the Intra Vas Device, which begin this week. Shepherd Medical -- the U.S.-based company that invented the IVD procedure -- has chosen Pollock to head its scientific advisory board.
The study has already recruited 50 men from British Columbia and Quebec who want to have vasectomies. As part of the study, they will have the devices inserted, assessed and removed. They will then undergo a vasectomy.
"It is a safety study, not a study to test effectiveness," says Roslyn Tremblay, a spokeswoman for Health Canada.
If the trials are successful, Pollock's team will likely request approval for studies to examine the effectiveness of implanting the devices for a longer term.
Early tests in the United States and Brazil have indicated the procedure successfully blocks sperm in humans. Clinical trials involving monkeys found the same result. Clinical trials are ongoing in the U.S., where the device has still not received approval from the Food and Drug Administration.
