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Jul 15, 2023

Male contraception in a post

Before the landmark Dobbs v. Jackson Women's Health Organization decision ended the constitutional right to abortion in the United States, Aaron Zeleske thought a vasectomy might one day make sense

Before the landmark Dobbs v. Jackson Women's Health Organization decision ended the constitutional right to abortion in the United States, Aaron Zeleske thought a vasectomy might one day make sense for him.

“My partner and I make decisions together and work on the direction of our life together. We don’t plan on having children, and it’s consistent with my values to share responsibility for contraception,” explains the 39-year-old environmental organizer.

But when the U.S. Supreme Court decision landed, Zeleske was done waiting. “I thought, ‘I need to get my act together and do this,’” says Zeleske, who lives in Wisconsin, where there’s a near-total abortion ban. “Given the current environment, vasectomy seems almost like a political act.”

In the wake of the June 24 decision overturning Roe v. Wade, interest in vasectomy has leapt significantly.

The Cleveland Clinic Center for Male Fertility saw a 2½-fold increase in vasectomy inquiries in July 2022 compared to July 2021, according to center director Sarah Vij, MD. “We’re also getting more young men without children, which was rare before,” she says. “The changes are very significant, and peers across the country all are seeing something similar.”

For decades, men have only had vasectomy or condoms as contraceptive choices, and many are interested in updated options. In one survey of 1,500 U.S. men aged 18 to 44, 70% said they are very or somewhat interested in new male contraception. And that was before the Dobbs decision.

Now, after decades of work, researchers are inching closer to a variety of male contraceptives, from a barrier method to the long-elusive “male pill.”

“Given the current environment, vasectomy seems almost like a political act.”

Aaron ZeleskeVasectomy patient

All this can’t come soon enough for Stephanie Page, MD, PhD, a male contraceptive researcher at the University of Washington School of Medicine in Seattle.

“We are facing what is becoming a crisis in unplanned pregnancies in this nation, and we know there are enormous health and economic consequences from unplanned pregnancies,” says Page. “We need expanded contraceptive options for men if we are going to protect the health and well-being of men, women, and their offspring.”

An estimated 5% of U.S. men ages 18 to 45 have undergone a vasectomy.

That’s lower than in some other Western nations, like Canada and the United Kingdom, where the procedure rates range from 17% to 22%.

And it’s lower than the parallel procedure for U.S. women, tubal ligation, which is close to 20%. Some experts find that concerning. “Every year in this country, 25 to 30 women die from tubal ligation,” says Marc Goldstein, MD, a vasectomy specialist at Weill Cornell Medicine in Manhattan. “No man in North America has ever died from a vasectomy.”

Vasectomy actually is a relatively simple procedure. The physician makes one or two small incisions or punctures in the scrotum to access the vas deferens, the tube that carries sperm. Then the tube is cut and the two ends sealed — with a tie, clip, stitches, or cauterization — so sperm can’t enter ejaculate fluid.

“It takes about 10 or 15 minutes, and patients can drive themselves home afterward,” explains Amin Herati, MD, director of men’s health at Johns Hopkins Medicine in Baltimore. Patients then need to take certain precautions afterward, such as no sex or heavy lifting for a week.

“No man in North America has ever died from a vasectomy.”

Marc Goldstein, MDWeill Cornell Medicine

Vasectomy is 99% effective in preventing pregnancy. By comparison, condoms are 98% effective when used perfectly, but 87% effective as they are typically used.

Vasectomy is not without risk, but complications are rare. About 1% to 2% of patients experience long-term pain that impacts their quality of life, Herati says, though treatments can help.

Often, the greatest downside of vasectomy is post-procedure regret, experts say. Up to 6% of patients later seek a reversal. “In my practice, the people who have the most regret are those who get a vasectomy in the midst of an active pregnancy and then the baby doesn’t carry to term. In the vacuum of that loss, patients really feel the hurt,” says Herati.

Vasectomy reversal is not simple. For one, it takes 4 to 6 hours. In addition, it’s not foolproof, with a success rate ranging from 73% to 91% depending on how it’s performed. Physicians therefore warn patients to see the procedure as permanent. And even for patients confident in their choice, experts say banking sperm sometimes makes sense.

That’s what Jackson Peven, 27, has chosen even though he’s quite sure he doesn’t want biological children. “If I ever do want kids, I plan to adopt because there are kids out there who deserve families,” says the Seattle software engineer.

Peven called for a vasectomy consultation soon after Dobbs. Although he doesn’t currently have a partner, hearing concerns from women friends sparked him to act.

“Vasectomy is a concrete thing I can do to help avoid putting a woman in a situation that would be so challenging,” he says. “But this is also for myself since I don’t want to deal with an unwanted pregnancy. It’s a win-win.”

When contraceptive pills were introduced in 1960, they transformed the lives of women and their partners. But a similar pill for men has long remained elusive.

For one, major drug companies are loath to invest in trials given prior failures and uncertain demand, observers say. The basics of human biology also complicate matters. “While women produce one to two eggs a month, ejaculate has over 100 million sperm in it,” says Page.

Then there are safety concerns. For example, in 2011, one study of male birth control was halted due to hormone-related side effects, including depression and other mood changes.

Recent efforts to develop a male contraceptive have been successful in reducing side effects while ensuring efficacy.

Farthest along is a male contraceptive gel that is applied to the shoulders. It’s a hormonal cocktail that stymies testosterone production in the testes — which is central to sperm development — and adds just enough back into the bloodstream to preserve such features as men’s low-pitched voices.

The gel, which is currently being tested with 400 couples, suppressed sperm production in 90% to 95% of men who used it consistently in a previous, smaller trial, says study co-lead Page. That degree of effectiveness is comparable to birth control pills for women.

“It’s easy. I just rub the gel on every day,” says trial participant Alex Springer, 28. “I also have regular sperm collections so they can check whether we need to add another form of birth control, but that hasn’t happened.”

Springer has appreciated the opportunity to participate, largely because his partner’s diabetes limits contraception options. “I’m a little sad that my time in the trial is ending and now we’re going to have to find an alternative birth control method,” he says.

If all goes as planned, next up for the gel will be a phase 3 trial in about two years with some 2,000 couples.

Meanwhile, Page, whose work is funded by a grant from the National Institutes of Health, is also aiming for a pill using a hormonal mechanism similar to that of the gel. That’s tough in part because oral compounds can metabolize quickly. So far, twice-daily dosing has been necessary, increasing the odds that men might miss doses.

Now, researchers have formulated a once-a-day option and are testing varied strengths to see how well they squelch sperm production. Although preliminary results look good, longer trials are necessary to confirm efficacy and safety, says Page.

Then there’s also the possibility of a long-acting injection, but that research is at an even earlier stage, focused only on the technique’s safety.

Overall, those involved say it might be 10 years before a hormone-based male contraceptive finally arrives on pharmacy shelves. But researchers say they are committed to the long haul.

“I’ve been at this for decades, and clinical trials can be slow and complicated, and at times it’s been discouraging,” says Page. Still, she’s encouraged by recent research advances as well as an uptick in trial volunteers following the Dobbs decision. “People tell us they feel an increased urgency to increase contraceptive options,” she says.

As some researchers pursue the hormone-based approach, others seek methods that avoid tampering with testosterone.

“Even if the side effects from [contraceptive] hormones are mild, people tolerate them differently. Also, patients with risk factors such as cardiovascular disease might want to avoid hormonal methods,” says Gunda Georg, PhD, a male contraception researcher at the University of Minnesota College of Pharmacy. “It’s about having different options.”

Georg has developed a male contraceptive that works by blocking a certain form of vitamin A that plays a role in sperm development. She says it’s not only 99% effective in mice and monkeys, it’s also safe. “We gave mice 100 times the dose, and they were fine,” she says.

The next step is human trials — no simple matter. “It’s very expensive to meet the standards necessary for FDA scrutiny,” says Georg. Her university therefore has licensed the compound to a small pharmaceutical company that has raised $15 million. Georg expects the trial to launch in early 2023.

Another promising approach focuses not on suppressing production of sperm but stifling their ability to reach an egg. Working with mice, researchers at Weill Cornell Medicine in Manhattan have successfully disabled an enzyme in semen that usually gets sperm to swim. Next up is to work with rabbits.

If that works well, they’ll be one step closer to a pill that’s taken shortly before sex — perhaps 30 to 60 minutes — and that lasts just a few hours. “The goal is a contraceptive you take only when needed,” explains Lonny Levin, PhD, one of the project’s co-leads.

“We can’t continuously have mostly a one-sided effort. The closer we can get to equity, the better off everybody will be.”

Alex Pastuszak, MD, PhDUniversity of Utah School of Medicine

Yet another approach is to physically bar sperm from leaving a man’s body.

One way to do that is to inject a gel into the vas deferens in a procedure similar to vasectomy.

The difference is the gel would dissolve, restoring fertility, explains Alex Pastuszak, MD, PhD, an assistant professor of urology at the University of Utah School of Medicine in Salt Lake City and consulting chief medical officer of Contraline, a company developing such a product.

“The goal is a ‘tunable’ gel, meaning that the product would last months or years depending on which version the patient chooses,” Pastuszak says. In September, Contraline started human trials in Australia to evaluate both the effectiveness and possible side effects of the gel.

“I’ve been in this space a long time and I get excited about very few things, but I’m super-excited about this,” says Pastuszak.

Men seem to find the approach compelling, too. In fact, thousands volunteered to participate before recruitment even began, according to Pastuszak. “I’m really encouraged by the number of men who are stepping up,” he says.

For Pastuszak, male contraception is partly a matter of fairness. “We can’t continuously have mostly a one-sided effort,” he says. “The closer we can get to equity, the better off everybody will be.”