Immune therapy with rituximab to restore ovarian function and fertility in autoimmune premature ovarian insufficiency
Official title: Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency - Double-blind, Placebo-contrelled, Randomized Study.
Run by Karolinska University Hospital · NCT07509840 · Data updated 2026-11-12
This trial will test whether the immune drug rituximab can restore ovarian function and improve fertility for women with autoimmune premature ovarian insufficiency.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 38 Years |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | rituximab |
| Locations | 2 sites (Stockholm and 1 other locations) |
| Status | Recruiting |
| Started | February 12, 2026 |
| Main results expected | December 31, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT07509840 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–38 with confirmed autoimmune POI (FSH >25 IU/L on two occasions, oligo/amenorrhea ≥4 months, and relevant autoantibodies), BMI 19–30, who want children and can use non-hormonal contraception during the 18‑month study period are ideal candidates.
✕Probably not a fit
Patients without autoimmune markers, with non‑autoimmune causes of POI, active severe infection, active hepatitis B, severe immunosuppression, JCV positivity, or known rituximab hypersensitivity are unlikely to benefit or are ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial gives women with confirmed autoimmune POI one of two rituximab treatment regimens and follows ovarian function over time. Eligibility requires autoimmune markers (for example 21‑hydroxylase antibodies or Addison's disease), elevated FSH on two occasions, age 18–38, and BMI 19–30. Participants who show a positive ovarian response after initial stimulation may be offered in vitro fertilization (IVF), and all participants undergo regular hormone and safety monitoring during the 18‑month study period. The protocol excludes patients with active severe infections, hepatitis B, severe immunosuppression, JCV positivity, or known hypersensitivity to rituximab.
Why it matters
Potential benefit: If successful, this approach could restore menstrual cycles and improve chances of pregnancy either naturally or via IVF in women with autoimmune POI.
How similar studies have gone: Evidence to date is limited to small case reports and early‑phase work suggesting B‑cell depletion can restore ovarian activity in some autoimmune POI patients, so this approach is promising but not yet proven in large trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. The subject has given their written consent to participate in the trial
2. Autoimmune POI (FSH \> 25 IU/L) including the presence of oligo/amenorrhea lasting at least 4 months, and elevated FSH levels (FSH \> 25 IU/L) confirmed on two separate occasions, with measurements taken at least 4 weeks apart and Addison's disease or ab positivity for 21-hydroxylase or other relevant autoantibodies (SCC, 17-OH, NALP5)
3. 18-38 years of age
4. Body mass index between 19-30
5. Willing to use effective non-hormonal contraceptive (such as intra uterine device (IUD), sexual abstinence, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) method during the 18-month study period
Exclusion Criteria:
1. Hypersensitivity to rituximab, any of the AxMPs, or any of the excipients (as detailed in the SmPC for the various IMPs)
2. Active, severe infection or JCV positivity
3. Active hepatitis B infection
4. Severe immunosuppression
5. Severe cardiac disease
6. Cancer
7. Benign tumours of the hypothalamus, pituitary, or ovarian pathology
8. Vaginal bleeding of unknown etiology
9. Hormone replacement therapy within four weeks prior study entry
10. Pregnant or lactating women
11. Concurrent treatment with other immunosuppressive drugs
12. Any vaccination within 4 weeks of infusion of study medication
13. Severe psychiatric disorder
14. Any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with rituximab or controlled ovarian hyperstimulation
15. Active thrombolic disorder (contraindicated for Ovirelle)
16. Moderate or severe impairment of kidney or liver function (contraindicated for Orgalutran)
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Where it's running
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Department of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, Sweden Recruiting -
Karolinska University Hospital
Stockholm, Sweden Recruiting
Study contacts
- Study coordinator: Angelica Lindén Hirschberg
- Email: angelica.linden-hirschberg@regionstockholm.se
- Phone: +46812373326
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.