Vasalgel is a polymer hydrogel that is injected into the vas deferens (the vessel that transports sperm) and blocks the flow of sperm. The quick procedure is similar to No-Scalpel Vasectomy (NSV), except the doctor injects the vas deferens with gel, instead of cutting it.
Vasalgel has no effect on orgasm or ejaculation, and seminal fluids will still be released (just not with sperm!).
Two common concerns regarding vasectomy are the development of sperm granulomas and pressure buildup. However, only a small percentage of men who have had a vasectomy experience chronic pain (1-2% according to the American Urological Association). Our current understanding of Vasalgel is that fluids can pass through the gel, but sperm cannot. This will likely reduce the incidence of back-pressure. 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 should not be an issue.
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, while Vasalgel is being developed in the United States to conform to the latest FDA and international codes of production and safety.
Our understanding is that Vasalgel works by blocking or filtering out sperm. In the past, RISUG (a related product) was described as working by shredding sperm with an electrical charge disturbance as they went past the contraceptive that lined the walls of the vas deferens. 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. Reversibility studies must be completed in men as well before Vasalgel can be marketed as a reversible male contraceptive.
In about 4-5 years if all goes well. We want to get Vasalgel on the market as soon as possible, but all the proper efficacy and safety testing needs to be completed. Vasalgel is currently undergoing animal testing, product qualification and safety testing, with first human clinical trial anticipated to begin in late 2018 or 2019. A larger trial the year after will give more men the opportunity to use it. If everything goes well, we hope to get regulatory approval for Vasalgel within a couple of years of that point. Our initial focus will be in the U.S., E.U. and Canada, with wider distribution to follow.
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 we won’t know exactly how much it will cost. It’ll have to cost enough to make the company sustainable, but tiered pricing will keep the cost within reach. We’ll also work to get it covered by insurance.
Once it is on the market, Vasalgel will be available like vasectomy and other contraceptive options. However, reversibility evidence will be important for men who may want children in the future. Men’s sperm count declines with age, so freezing sperm as a backup is also an option for men who want to make extra sure they can have children in the future.
We don’t yet know where the first trials will be held. Sign up for the email list and we’ll let you know as soon as we know!
The first clinical trials will likely be limited to men who are okay with potential irreversibility (i.e. don’t want any more children), since the clinicians won’t be able to promise reversibility until a reversibility study is completed. For all trials, the clinicians supervising the trial will determine selection criteria and final study participants. We’d like to be able to say that the longest-time fans or earliest donors or biggest donors would get priority, but unfortunately it may not work that way—we may not have much choice in what regulators permit. Sign up for the email list to get updates as it takes shape. And donate to help us get it to market, so everybody has access!
Unfortunately not! RISUG is not yet on the market in India, and clinical trials of RISUG are only for Indian men who live near the study sites. Recent media reports indicate that it might be on the market in the next year or so.
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. Reversal was also successful in rabbits, and that paper was published in April 5, 2017. A study confirming efficacy in monkeys was published on February 6, 2017. Be sure to sign up for our email list to get summaries of study results and announcements for publication availability.
Share the news about Vasalgel with friends and colleagues; “like” us on Facebook, then sign up as a supporter of the new 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!
They have their downsides, but we think the two types of IUDs for women are the closest thing to Vasalgel in terms of being long-acting and highly effective. You can read more about them at IUD Divas. Condoms plus fertility awareness can work for the super-careful and motivated. And for those finished having children, no-scalpel vasectomy (NSV) by one of the ultra-experienced high-volume providers can be an option. For more about contraceptive options, see Bedsider.org.
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. However, you can donate to the venture’s nonprofit parent, Parsemus Foundation, to help keep the project moving! You’ll find the donation link on each of Vasalgel’s pages. And 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!
Big pharma experimented with repurposing its female contraceptives for male use, but has not remained interested in male contraception since that approach failed—perhaps because it is more lucrative to sell ongoing hormonal birth control to women. Big pharma already has most of the market in developed countries, and selling a method to women’s partners would cannibalize existing sales. Smaller companies are often scared off by the liability or just don’t have the money. In addition, a pure for-profit company might make the price so high as to reduce access. Vasalgel’s development is being supported by Parsemus Foundation as a social venture to ensure low costs and wide availability—so we have to be careful about whom we choose as partners. However, as development progresses, we may seek other social-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? Because 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.
We expect that Vasalgel will be as effective as a vasectomy. In a one-year rabbit study, we saw no sperm, starting 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.
It is certainly possible that Vasalgel could be used in the Fallopian tubes to block the egg from passing through on its way to the uterus. While there has been some experimental work in this area, our focus is on getting Vasalgel to market for men, since there are currently only two contraceptive options for men (vasectomy and condoms). We hope that in the future, this line of research can be followed up to result in a nonhormonal contraceptive option for women, too!
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. To support research on a method that could reduce HIV transmission, check out the Clean Sheets Pill.
Regulatory agencies require a number of steps in the process of approving a new medicine or treatment, and some can only be accomplished with animal models. However, the Parsemus Foundation (which supports Vasalgel research) is also involved in animal welfare, and cannot accept current U.S. research animal care and housing standards in good conscience. Thus for studies that are absolutely required, we are working to “make change within the system” by raising the bar on animal care and showing research facilities that there is another way to do things (and that people are willing to pay for it). The foundation requires, even in the U.S., that animal studies be conducted under the strict European animal welfare standards and follow the recommendations of the UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research. In addition to making their lives as comfortable as possible, animals are adopted out whenever possible. We hope to have your support in paying for these improvements! We have already seen a difference, with some facilities adopting the improvements for other animals in their facility too. It is not a perfect solution, but there is no other way to get humans a new contraceptive option. For more information, check out the Research Requirements for Animal Welfare.
Probably, but our first priority is getting Vasalgel developed for human use. In addition, since it does not change hormones, Vasalgel cannot substitute for pet neuter (hormone elimination is necessary to stop behavior such as roaming in dogs and spraying in cats). The demand would be limited to those seeking a reversible, non-behavior-changing option. However, the Parsemus Foundation (which supports the work on Vasalgel) also 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 page at Hormone-Sparing Male Sterilization.