Vasalgel FAQ

Vasalgel FAQ

Find Your Answers Here!

Vasalgel is a polymer material that is injected into the vas deferens (the vessel that transports sperm), where it sets up as a gel and blocks the flow of sperm. The quick procedure is similar to No-Scalpel Vasectomy except the doctor injects the vas deferens with Vasalgel instead of cutting it. This video is a representation of the process.
Vasalgel is designed to block sperm but not other seminal fluids so it is expected to have minimal to no effect on orgasm or ejaculation. This, of course, can only be determined with clinical experience. Clinical studies in India of a similar contraceptive (RISUG) have found that following contraception, ejaculates contained seminal fluids (just not with sperm!) (see Sharma et al., 2001).
The specific side effects of Vasalgel can only be determined through clinical experience. We do know that two common concerns regarding vasectomy are the development of sperm granulomas and pressure buildup. Sperm granulomas are formed when the vas deferens is severed in a vasectomy and sperm leak into surrounding tissue. Since injection of Vasalgel does not involve cutting the vas deferens, this may not be an issue. A small percentage of men who have had a vasectomy experience chronic pain (1-2% according to the American Urological Association), which may be due to back pressure. Vasalgel is designed such that fluids may pass through the gel, but sperm cannot. This will possibly reduce the amount of back-pressure.
It’s “VAH-zuhl-gel” or “VAY-zuhl-gel,” your choice—even our team can’t agree! It’s named after the vas deferens.
They’re similar, but not the same. Although Vasalgel and RISUG® are based on the same concept of using a polymer gel injected into the vas deferens, the formulations are not exactly the same. And RISUG has been developed and tested in India over multiple decades.
The intent is that Vasalgel works by primarily blocking sperm. In the past, RISUG (a related product) was described as working by rupturing sperm with an electrical charge disturbance (see review in Thukar et al., 2013). Vasalgel makes no such claims.
The idea is to develop a fully reversible long-acting male contraceptive, and recently-completed rabbit studies showed rapid restoration of sperm flow. This was accomplished by flushing the Vasalgel from the vas deferens with an injection of sodium bicarbonate (baking soda) solution. Additional reversibility studies must be completed before Vasalgel can be marketed as a reversible male contraceptive.
We want to get Vasalgel on the market as soon as possible, but all the proper efficacy and safety testing has to be completed. Vasalgel is currently undergoing pre-clinical testing, product qualification and safety testing. First-in-Man studies and subsequent larger trials will likely need to be done, and their precise duration and scope must be determined. If everything goes well, we hope to gain regulatory approval for Vasalgel after these studies are finished.
Vasalgel’s developer is committed to making it affordable and widely available—close to cost in low-income countries, and affordable to those in every income level in the U.S.—but until the process is further along, and insurance coverage limits are determined, we won’t know exactly how much it will cost.
The age requirements for Vasalgel will be determined by our regulatory approval process and through clinical experience. Once it is on the market, Vasalgel will be available like vasectomy and other contraceptive options.
It is not yet known where the first trials will be conducted. Sign up for the email list to get updates. And donate to help us get it to market, so everybody has access!
It is yet to be determined how people will be chosen since the studies are not designed yet. Sign up for the email list to get updates. And donate to help us get it to market, so everybody has access!
RISUG is not yet on the market in India, and clinical trials of RISUG are currently restricted to Indian men who live near the study sites. Recent media reports indicate that it might be on the market in the near future.
A preclinical study showing the efficacy of Vasalgel in rabbits was published on March 30, 2016 in Basic & Clinical Andrology, a peer-reviewed, open-access journal. A reversal study in rabbits was also published on April 5, 2017. An efficacy study in monkeys was published on February 6, 2017. Be sure to sign up for our email list to get announcements of publication availability.
Share news about Vasalgel with friends and colleagues; “like” us on Facebook, then sign up as a supporter of the Male Contraception Initiative advocacy organization. Finally, if you see any stories online with inaccuracies about Vasalgel, correcting those in the story’s comments section is an area where we could really use help!
Please consult your physician so you can be fully informed about any contraceptive options. There are IUD options for women that you can read about at IUD Divas. Condoms plus fertility awareness, as well as No-Scalpel Vasectomy, are also available. For more information about contraceptive options, see Bedsider.org.
Yes, you can make a tax-deductible donation to Parsemus Foundation to keep the Vasalgel project moving forward! You’ll find a donation link on each page of our website. When you donate, look for the heading “Please designate how your donation is to be used.” If you choose “Vasalgel,” we’ll allocate your entire donation to that project.
Vasalgel is being developed as a social venture—designed to make enough profit to be financially sustainable, but with the primary goal to make an affordable, effective male contraceptive widely available. So there’s no opportunity for getting rich quick. We are seeking socially-minded donors/investors of $50,000 or more (accredited investors and investment funds)—so if you know of anybody in that category who would like to see this succeed, please spread the word!
Vasalgel’s development is being supported by Parsemus Foundation as a social venture to ensure low cost and wide availability—so we have to be careful about who we choose as partners. However, as development progresses, we may seek other socially-minded organizations to help us take it to the next level.
Crowdfunding is a great idea for Vasalgel. Kickstarter says they will not accept this type of project (too medical) even though supporters petitioned, but IndieGoGo would be a better fit. So why not right away? Crowdfunding experts have advised us to use crowdfunding to help fund human clinical trials – not preclinical work – because most folks want to support the final stages of the project. Depending on other fundraising initiatives, we may engage in crowdfunding in the future.
The effectiveness of Vasalgel can only be determined through clinical studies. In a one-year rabbit study, we saw no sperm shortly after implantation, which is a very good sign. Studies also showed effectiveness in baboons and rhesus monkeys for over a year.
We don’t know yet how many years the effect will last for Vasalgel; upcoming research will help produce those answers. A similar vas occlusive male contraceptive called RISUG has been in patients for eight years with no reported issues (Sharma et al., 2001). Until we have more data, we may recommend that men who receive Vasalgel have their ejaculate tested for the presence of sperm to ensure that the contraceptive effect continues.
Until proper preclinical and clinical studies are performed, we cannot assess whether Vasalgel would be appropriate for women or not. Our focus is on getting Vasalgel to market for men, since they currently have only two contraceptive options (vasectomy and condoms).
No, it’s not likely to stop the spread of HIV, since quite a bit of HIV lives in the seminal fluid and only about a third of HIV lives on the sperm. So it will be most appropriate for committed couples, or as a backup to condoms. For more information on a method that could reduce HIV transmission, check out the Clean Sheets Pill.
Unfortunately, the use of animals is often necessary for the development and approval of medical devices and the development of Vasalgel falls under this requirement. Parsemus Foundation (which supports Vasalgel research) is also involved in animal welfare. For animal studies that are absolutely required, we are working to “make change within the system” by raising the bar on animal care. The foundation requires, even for pre-clinical studies conducted in the U.S., that animal studies be conducted under the stricter European animal welfare standards and follow the recommendations of the UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research. These requirements include, in addition to making the lives of study animals as comfortable as possible, that animals are adopted out whenever possible. We hope to have your support in financing these improvements! We have already seen progress, with some facilities adopting our required improvements for other study animals. It is not a perfect solution, but we feel is the best balance of the welfare of study animals with the need for developing a new contraceptive option for humans. For more information, check out the Research Requirements for Animal Welfare.
Whether Vasalgel is effective in dogs and cats would need to be independently determined. The first priority is getting Vasalgel developed for human use. Parsemus Foundation (which supports the work on Vasalgel) funds research on nonsurgical sterilization options for domestic animals – including calcium chloride, a well-studied and very affordable option for cats and dogs that is available for use now, worldwide, for about a dollar a dose. Do you work with or support spay/neuter organizations? Please spread the word about calcium chloride nonsurgical pet neuter! For hormone-sparing options for pets that are available now, see our Hormone-Sparing Male Sterilization page.
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