A Karolinska Institutet pilot study shows that immunotherapy may be able to accelerate egg maturation in women with autoimmune POI (premature ovarian insufficiency), which usually leads to infertility. After treatment, 3 out of 10 women gave birth to healthy babies.
Just over 3 percent of women worldwide are affected by premature ovarian insufficiency, or POI, a condition in which the ovaries stop functioning before the age of 40. POI can have a variety of underlying causes, involving both autoimmune mechanisms and other factors such as genetics. This condition leads to a significant reduction in fertility. In the current study, researchers therefore sought to investigate whether immunotherapy temporarily makes the ovaries more responsive to hormonal stimulation in women with POI caused by autoimmunity.
The study involved 12 women aged 18 to 35 with autoimmune POI. Two of them withdrew from the study before starting treatment. All other participants received ovarian hormone stimulation before and 4 to 6 months after treatment with rituximab. Rituximab is an approved and well-established treatment for a variety of autoimmune diseases and cancers.
None of the women responded to stimulation before treatment with rituximab. However, after treatment, six out of 10 women developed follicles that responded to ovarian stimulation and were able to retrieve eggs.
The results indicate that some women still have eggs left that can be activated when the autoimmune process is suppressed. ”
Angelica Linden Hirschberg, lead author of the study and professor at the Department of Women and Child Health at Karolinska Institutet
In five of the women, mature eggs may have been frozen or fertilized. Embryo transfers were subsequently performed on three of them, and all three gave birth to healthy babies. For safety reasons, embryo transfer was performed within 1 year after treatment. One case of serious side effects was reported, but this was related to hormonal stimulation rather than immunotherapy.
Women with autoimmune POI often also have other autoimmune diseases. All of the women who responded to treatment had autoimmune Addison’s disease, in which the immune system destroys the adrenal glands.
The study is a so-called proof-of-concept study, with no control group and a small number of participants, so the results should be interpreted with caution.
“This is a first step. Large randomized studies are needed to determine whether this method is effective and safe,” says Angelica Linden Hirschberg. The research team has just begun doing just that.
The study was carried out in collaboration with researchers from Karolinska Institutet, Karolinska University Hospital and the University of Bergen. The research was funded by the Swedish Research Council, the Knut and Alice Wallenberg Foundation, the Novo Nordisk Foundation, the Stockholm Region, and others.
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Reference magazines:
Hershberg, Alabama others. (2026). Immunotherapy for fertility in autoimmune premature ovarian insufficiency. NEJM records. DOI: 10.1056/EVIDoa2500303. https://evidence.nejm.org/doi/pdf/10.1056/EVIDoa2500303
