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New hope for fertility: drug may reverse early menopause in autoimmune patients

NCT ID NCT07509840

Disease control Sponsor: Angelica Lindén Hirschberg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether an immunomodulatory drug (rituximab) can improve or normalize ovarian function in women aged 18-38 with autoimmune premature ovarian insufficiency (POI). Participants receive either rituximab or a placebo, and those who respond may undergo IVF. The goal is to restore fertility, but ongoing management may still be needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 38 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

autoimmune primary ovarian failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune prematur ovarian insuffience

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Obstetrics and Gynecology, Karolinska University Hospital

    RECRUITING

    Stockholm, 171 76, Sweden

  • Karolinska University Hospital

    RECRUITING

    Stockholm, 17176, Sweden