Immunotherapy may temporarily restore fertility in patients of premature menopause

by Anna Björklund, Karolinska Institutet

edited by Lisa Lock, reviewed by Andrew Zinin

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A pilot study from Karolinska Institutet shows that immunotherapy may enable the stimulation of egg maturation in women with autoimmune POI (premature ovarian insufficiency)—a condition that usually leads to infertility. Three out of 10 women gave birth to healthy babies following the treatment.

Just over 3% of women worldwide are affected by premature ovarian insufficiency, POI—a condition in which the ovaries cease to function before age 40. POI can have various underlying causes, with both autoimmune mechanisms and other factors such as genetics playing a role. The condition leads to significantly reduced fertility. The researchers therefore sought to investigate in the current study whether immunotherapy could make the ovaries temporarily responsive to hormonal stimulation in women with POI caused by autoimmunity.

The study included 12 women ages 18–35 with autoimmune POI. Two of them withdrew from the study before treatment began. All other participants underwent ovarian hormone stimulation both before and four to six months after treatment with the drug rituximab, which is an approved, well-established drug for various autoimmune conditions and cancers. The results are published in the journal NEJM Evidence.

6 in 10 developed follicles

Before treatment with rituximab, none of the women responded to the stimulation. After treatment, however, 6 out of 10 women developed follicles that made it possible to retrieve eggs in response to ovarian stimulation.

"The results show that in some women there remains an egg reserve that can be activated when the autoimmune process is suppressed," says the study's first author, Angelica Lindén Hirschberg, professor at the Department of Women's and Children's Health at Karolinska Institutet.

In five of the women, mature eggs could be frozen or fertilized. Three of them later had embryos transferred, and all three gave birth to healthy babies. For safety reasons, embryo transfer took place no earlier than one year after treatment. One case of a serious side effect was reported and was linked to the hormone stimulation, not to the immunotherapy.

It is common for women with autoimmune POI to also have other autoimmune diseases. All women who responded to the treatment had autoimmune Addison's disease, a condition in which the immune system destroys the adrenal glands.

The study is a so-called proof-of-concept study without a control group and involved a small number of participants, which means the results must be interpreted with caution.

"This is a first step. To determine whether the method is effective and safe, larger, randomized studies are required," says Hirschberg. The research team has just launched such a study.

Publication details

Angelica Lindén Hirschberg et al, Immunotherapy for Fertility in Autoimmune Premature Ovarian Insufficiency, NEJM Evidence (2026). DOI: 10.1056/evidoa2500303

Journal information: NEJM Evidence

Key medical concepts

ImmunotherapyMenopause, PrematureRituximabAddison Disease

Clinical categories

Obstetrics & gynecologyReproductive healthWomen's healthAllergy and immunology Provided by Karolinska Institutet Who's behind this story?

Lisa Lock

BA art history, MA material culture. Former museum editor, paramedic, and transplant coordinator. Editing for Science X since 2021. Full profile →

Andrew Zinin

Master's in physics with research experience. Long-time science news enthusiast. Plays key role in Science X's editorial success. Full profile →

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