Why Male Infertility Has Been Ignored for Decades—And How That's Finally Changing

Male infertility affects roughly half of all couples struggling to conceive, yet men have been largely left out of infertility treatment development for decades. While women have shouldered the physical, emotional, and financial burden of treatments like in vitro fertilization (IVF), emerging therapies now promise to address male infertility directly—potentially transforming how couples approach conception.

Why Has Male Infertility Been Overlooked for So Long?

The neglect of male infertility stems from a perfect storm of social stigma, lack of awareness, and gender bias. "Twenty years ago, or so, male infertility was not widely acknowledged or discussed. This reticence was driven by several factors—a lack of data highlighting prevalence of the problem, social stigma that led men to feel shame and avoid medical care, and a gender bias that framed infertility solely as a 'women's issue,'" explained Florent Ferre, chief executive officer of Igyxos, a biotech company developing new male infertility treatments.

The disconnect between reality and perception is striking. A survey found that one in five men believed women are most likely to experience fertility issues, despite the fact that 50% of fertility problems within heterosexual relationships stem from male infertility. Even more concerning, only 44% of men surveyed were aware that infertility affects men at all.

Meanwhile, sperm counts have been declining at an alarming rate. Research published in Human Reproduction Update revealed that sperm counts have fallen by more than 50% over the past five decades, exacerbating the underlying problem. Male infertility can result from multiple factors, including low sperm counts, poor sperm motility, erectile dysfunction, and insufficient testosterone levels.

The Heavy Burden Women Bear in Current Infertility Treatment

Today's standard treatment for infertility—IVF—places nearly all the physical burden on women, even when male infertility is the primary issue. The procedure involves stimulating the ovaries with hormone treatments to produce healthy eggs, retrieving those eggs through surgery, fertilizing them with sperm in a laboratory, and then transferring embryos back to the uterus.

The costs and side effects are substantial. The average cost of one IVF cycle in the United States is $21,600, and only 25 to 30% of people become pregnant after a single cycle. Most couples undergo two to three cycles, meaning they spend around $50,000 on average for treatment. Even worse, four IVF cycles have a success rate of only about 60%, and success rates have declined over time as more women postpone motherhood until later in life.

Beyond cost, women endure painful daily hormone injections with significant side effects. These protocols alone lead to discontinuation rates as high as 35%, meaning more than one in three women stop treatment before completion. "Women still bear the 'physical burdens of painful, costly, and taxing IVF procedures that offer low chances of success after one cycle and no guarantees of success even after multiple cycles,'" said Ferre.

How Are New Male Infertility Treatments Different?

For decades, the only option for male infertility was intracytoplasmic sperm injection (ICSI), introduced in the 1990s. This technique involves injecting live sperm directly into eggs in a laboratory setting, but it still requires women to undergo the full IVF protocol—even though they are not infertile themselves. Critically, ICSI does not address the underlying cause of male infertility.

A new approach is emerging. Igyxos is developing IGX12, a humanized monoclonal antibody designed to target a root cause of infertility: hormone deficiency. The drug works by encouraging follicle-stimulating hormone (FSH)—a critical hormone that regulates the development of both eggs and sperm—to bind efficiently to its receptor, promoting the production of more reproductive cells.

Unlike daily hormone injections, IGX12 is administered as a once- or twice-monthly injection, significantly reducing treatment burden. The goal is to shift the treatment burden from women to a more balanced approach that addresses male infertility directly.

Steps to Understanding the Promise of New Male Infertility Treatments

• Safety Profile: IGX12 successfully completed phase 1 trials in December, demonstrating an excellent safety profile at all tested dose levels (20 and 40 micrograms per kilogram), with no serious adverse effects observed.
• Pharmacokinetic Advantages: The drug's pharmacokinetic profile—how the body absorbs and processes it—showed gradual absorption and a slow elimination half-life, meaning it remains in the system longer and requires less frequent dosing.
• Potential Clinical Impact: For women, IGX12 could improve the odds of IVF success without adding unduly to treatment burden, potentially raising success rates with only a single injection per IVF cycle.

What's Next for Male Infertility Treatment?

Igyxos is poised to begin phase 2 studies soon, with trials expected to start in leading fertility centers across Europe in 2026. The company received a €5.7 million (approximately $6.59 million) grant from the French Government in October to fuel these trials.

"The anticipated phase 2 trials could prove how advantageous the technology is for people experiencing infertility," said Ferre. For men specifically, addressing the underlying hormone deficiency could improve fertility outcomes without requiring their partners to undergo invasive procedures.

The shift toward treating male infertility directly represents a long-overdue change in reproductive medicine. By developing treatments that address the root causes of male infertility rather than simply working around them, researchers are finally acknowledging that infertility is not exclusively a women's health issue—and that couples deserve solutions that distribute the burden more fairly.