Isotretinoin, or Accutane, is an acne drug that may help stimulate sperm production in some men with infertility. (Image credit: SEBASTIAN KAULITZKI/SCIENCE PHOTO LIBRARY via Getty Images (background); evemilla via Getty Images (overlay))
A small study has found that the widely used acne drug Accutane may be used to treat male infertility.
For men with infertility due to very low or no sperm count, the only treatment option is surgery to remove sperm directly from the testicles for use in in vitro fertilization (IVF). However, this is a major operation that comes with discomfort, potential risks such as infection, and a long recovery period. What’s more, sperm is only recovered after the surgery in about half of cases.
Now researchers are exploring an alternative: isotretinoin, better known as Accutane, a drug that has been used for decades to treat severe acne. In a small study published in July in the Journal of Assisted Reproduction and Genetics, the drug boosted sperm production in some men who initially ejaculated with little or no sperm.
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“The idea that a well-studied drug can stimulate spermatogenesis [sperm production] in men with severe spermatogenesis disorders is exciting because it opens up the possibility of a non-surgical treatment for men who would otherwise require invasive sperm retrieval from their testicles,” Dr. Justin Howman, an assistant professor of urology at Cedars-Sinai Medical Center who was not involved in the study, told Live Science in an email.
“However, the study is small, preliminary, and needs to be replicated in larger randomized trials before we can consider it a real breakthrough,” he cautioned.
Dr. Brian Levine, founder and practice director of CCRM Fertility of New York, who was not involved in the study, also expressed cautious optimism about the results.
“The prospect of helping a patient avoid the pain, recovery time, and emotional stress associated with surgery is truly exciting to me and my colleagues,” he wrote in an email to Live Science. However, “this is not a panacea, and much more research remains to be done,” he added.
So how can a skin drug help men produce sperm?
Previous research has shown that infertile men often have low levels of retinoic acid in their testicles. This molecule, a derivative of vitamin A, is essential for normal sperm development. It controls the development of immature germ cells into mature sperm and promotes the release of mature sperm into the seminiferous tubules of the testicles. This connection led scientists to investigate isotretinoin, a compound that mimics natural retinoic acid, as a potential way to stimulate sperm production.
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For the study, the researchers enrolled 26 men with non-obstructive azoospermia, a condition in which there are no sperm in the ejaculate due to problems with sperm production, and four men with cryptozoospermia, in which there are extremely low sperm counts in the ejaculate.
All participants took 20 mg of isotretinoin twice daily for at least six months. Their blood, hormone and sperm counts were closely monitored at several points during the study.
Of the 30 men in the study, 11 began producing motile sperm (sperm that can swim effectively) in their ejaculate. This allowed these men and their partners to begin IVF without the need for surgical sperm collection. This treatable group included all four men with cryptozoospermia and seven men who had previously produced no sperm at all.
For the remaining men who still had no sperm in their ejaculate after treatment, doctors had to resort to surgery to collect sperm for IVF. However, after taking isotretinoin, the procedure took much less time — an average of 63 minutes, compared with 105 minutes before treatment. (The report does not say why surgery was more effective after Accutane.)
The researchers reported that at the time of publication of the study, nine IVF cycles had been performed with sperm collected after isotretinoin treatment, resulting in multiple healthy embryos, several ongoing pregnancies and one live birth.
The treatment wasn’t without side effects, however. All 30 men developed dry skin and chapped lips, and about half reported irritability after treatment. Some also experienced rashes and increased cholesterol and triglyceride levels. Because isotretinoin can affect these levels and liver function, patients need to have their blood tested regularly during treatment, Howman said. Doctors recommend that patients taking Accutane for acne have periodic blood tests, although they disagree on how often they should be done.
“It’s important to note that we don’t yet know the optimal dose, duration, or long-term safety of isotretinoin for men seeking fertility,” he said. “Another limitation is that response rates are unknown, and many men may not benefit at all.”
Howman cautioned that until larger study data becomes available, isotretinoin should not be used to treat male infertility outside of clinical trials.
Isotretinoin is safe for women to take outside of pregnancy, but it is considered extremely dangerous during pregnancy because it can cause serious birth defects. The risk is so great that the drug comes with a black-box warning and strict contraception requirements while taking it.
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“The situation is different in men,” Howman said. The drug does not appear to damage sperm DNA and poses no risk to reproductive partners or future children. “In fact, this new study suggests that it may have a paradoxical beneficial effect by enhancing sperm production in some men.” That highlights the “significantly different biological context” of the male and female reproductive systems, he added.
Looking to the future, the researchers hope to learn which male infertility patients are most likely to benefit from isotretinoin; how to precisely time and dose treatment; and whether the drug can improve sperm quality and fertility outcomes.
The possibility that a simple course of oral drugs could restore sperm production in some men “would be a huge shift in our approach to male infertility,” Levin says. “It offers a new level of hope — not just hope of finding sperm, but hope of restoring natural biological function.”
Disclaimer
This article is for informational purposes only and does not provide medical advice.
Clarissa Brincat, Live Science contributor
Clarissa Brincat is a freelance writer who specializes in health and medical research. After earning a master's degree in chemistry, she realized that she enjoyed writing about science more than doing it. She learned how to edit scientific articles as a chemistry editor, then moved on to a medical writing position at a healthcare company. Writing for doctors and experts is challenging, but Clarissa wanted to communicate with a wider audience, which naturally led her to freelance writing in the health and science space. Her work has also appeared in Medscape, HealthCentral, and Medical News Today.
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