There's a birth control method new to the U.S. that just might change the way men and women look at contraception forever. This procedure is for men, it's pill- and hormone-free, takes around 15 minutes to complete, is inexpensive and reportedly reversible. Oh — and it's been around for decades.
The practicality of birth control methods for men has been a long-standing debate. Proponents argue that the male species is ready to take responsibility for their procreative abilities, while opponents remind us that if it's difficult enough for women to remember to take a pill each month (we've all been there, ladies), what makes it any easier for a man — who doesn't have a direct physical consequence to use as a monthly reminder — to do the same?
And that's why this procedure — called Reversible Inhibition of Sperm Under Guidance (conveniently shortened to RISUG) — shows such promise. A polymer gel, called Vasalgel in the U.S., is injected into each vas deferens during a minor surgical procedure. It quickly hardens into what Elaine Lissner, director of medical research at the Parsemus Foundation, described to AfterDarkLA as a mesh or Swiss cheese-like structure.
NOTE: The vas deferens are the tubes responsible for transporting sperm from the testes to the penis during ejaculation. The highway to heaven, if you will.
Stay with me here, your mind is about to blow. (Pun intended.)
This hole-y structure creates a sort of fence through which seminal fluid can — and will — flow without obstruction, but the little holes are about two microns too small for sperm to pass through. And if they do, they essentially strip themselves useless.
But how do researchers know that? Lissner described a “cool” study already completed in the U.S. during which colored microbeads of different sizes were sent through hardened Vaselgel. The microbeads unable to make it through unscathed were about three microns wide — the size of the head of sperm.
The Parsemus Foundation is the U.S. entity in charge of bringing this method to the States and preparing it for FDA approval and public distribution. The RISUG procedure has been in clinical trials in India for about 20 years, and now Parsemus is instating similar testing in the U.S. with Lissner at the helm. Day-to-day operations are headed by Gary Gamerman of Seraphim Life Sciences Consulting, an expert in manufacturing and regulatory matters.
Lissner already has been spreading the RISUG word as director of the Male Contraception Information Project for years.
“Parsemus bought the rights to RISUG in 2010 for use everywhere outside of India,” Lissner said. “The Indian team is still doing trials, and we're on a parallel path. We're going full speed ahead following all FDA standards, even starting with manufacturing in an FDA-approved facility. We're basically going back and dotting every 'i' and crossing every 't'.”
This preemptive — though expensive — starting point is meant to avoid any potential hurdles in the future, something that has affected the timeliness of RISUG's India-based research results. Lissner's team is working to gain Medical Device Approval and is in the midst of first-phase animal trials, the results of which are expected to be complete in the fall.
“We have rabbit studies starting now and hope to start human studies by end of the year,” Lissner said.
She says the gel product itself should basically be the same, but they've made some changes in the manufacturing process. For example, while the Indian team is using radiation polymerization, Parsemus researchers are using chemical polymerization.
“We're trying not to get too excited until we have the rabbit results in hand to make sure the gel we made works as well as what they are using in India,” Lissner said. “But our biggest hurdle will be that we won't be able to promise reversibility right away. It's been reversible in animal studies in India and in the few men who've requested it there, but [reversibility] is what makes [RISUG] special.”
RISUG is apparently strong enough to remain sturdy in the vas deferens for more than a decade, but it can be broken down using a baking soda-based solution and in just a few months healthy sperm can swim obstruction-free and ready to make babies.
But possibly the most appealing aspect to RISUG is its neutrality on the current contraception/abortion battle. Anyone opposed to contraception use as pregnancy prevention with a pro-life argument doesn't have a whole lot to stand on with Vasalgel.
“This is about as far away from the egg as you can get,” Lissner said. “People who are opposed to even vasectomies can be opposed to this, but it really gets away from the abortion issue.”
Lissner said this project is the largest — monetarily speaking — that Parsemus has taken on and she's happy to see RISUG and Vasalgel gaining notoriety in the media. To help the cause, share this article or sign this petition to let those funding the research know how much the American public wants Vasalgel.
There's even an option to sign up to be notified of human trials currently in the planning phase. Interested?