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Study of Rituximab Treatment for Women with Autoimmune Premature Ovarian Insufficiency to Improve Fertility

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What is this study about?

This study focuses on Autoimmune Premature Ovarian Insufficiency, a condition where the ovaries stop working properly before age 40 due to the immune system attacking the body’s own tissues. The research evaluates the effectiveness of rituximab, a medication that affects the immune system, in helping women with this condition regain ovarian function and improve their fertility.

The study will compare the effects of rituximab treatment against placebo to determine if the medication can help with egg retrieval after hormonal stimulation of the ovaries. The treatment involves receiving rituximab through infusion into a vein, with a maximum daily dose of 1 gram and a total dose of up to 4 grams over a 28-day period.

Throughout the study, participants will be monitored for changes in their menstrual cycles, hormone levels, and overall health. The research will track various aspects of ovarian function, including the possibility of natural menstrual periods returning and successful egg retrieval after treatment. The total duration of participation in the study is 19 months, during which various health measurements will be taken to assess the treatment’s effectiveness and safety.

1 Initial treatment phase

You will receive either rituximab or a placebo through an infusion (medication given directly into a vein)

The treatment will be administered under medical supervision in a clinical setting

You will not know whether you are receiving rituximab or placebo, as this is a double-blind study

2 First evaluation period (4-6 months)

After 4-6 months from your last treatment, you will undergo controlled ovarian hyperstimulation (a procedure to stimulate egg production)

Medical staff will attempt to retrieve eggs following the stimulation

Your hormone levels will be monitored, including follicle-stimulating hormone (FSH) and other relevant markers

Blood tests will be performed to measure your B-cell count and antibody levels

3 Second evaluation period (12 months)

A second egg retrieval attempt will be performed if you received rituximab treatment

Your hormone levels will be monitored again

Additional blood tests will be conducted to track changes in your immune system

4 Ongoing monitoring (19-month period)

Regular monitoring of menstrual bleeding patterns

Tracking of ovulation through blood tests measuring progesterone levels

Assessment of your quality of life using standardized questionnaires

Monitoring for any side effects or adverse reactions

Regular check-ups to ensure your safety throughout the study period

5 Study completion

Final evaluation of all measured parameters

Completion of final quality of life assessments

Final blood tests and hormone level measurements

Documentation of any changes in your ovarian function throughout the study period

Who Can Join the Study?

  • Must provide written informed consent to participate in the study
  • Must be diagnosed with autoimmune POI with:
    • Irregular or absent menstrual periods for at least 4 months
    • High FSH levels (above 25 IU/L) confirmed twice, at least 4 weeks apart
    • Either Addison’s disease or presence of specific antibodies (21-hydroxylase, SCC, 17-OH, or NALP5)
  • Must be between 18 and 38 years old
  • Must have a body mass index (BMI) between 19 and 30
    • BMI is a measure of body fat based on height and weight
  • Must agree to use effective non-hormonal contraception during the 18-month study period, such as:
    • Intrauterine device (IUD)
    • Sexual abstinence
    • Male or female condoms (with or without spermicide)
    • Cap, diaphragm, or sponge with spermicide
  • Must be female

Who Cannot Join the Study?

  • Age below 18 or above 40 years
  • Male patients (study is for females only)
  • Known pregnancy or currently breastfeeding
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • History of severe allergic reactions to biological treatments
  • Presence of other autoimmune disorders requiring immunosuppressive therapy
  • Active or recent cancer (within last 5 years)
  • Severe heart, liver, or kidney disease
  • Recent live vaccinations (within 4 weeks before treatment)
  • Current participation in other clinical trials
  • Mental conditions that could affect ability to provide informed consent
  • History of blood disorders or significant bleeding problems
  • Use of prohibited medications that could interfere with the study treatment
  • Inability to comply with study procedures and follow-up visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Region Oerebro Laen Orebro Sweden
Region Vaesterbotten Umea Sweden
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland Norrkoping Sweden
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not yet recruiting
30.09.2025

Trial locations

Investigated drugs:

Rituximab is a medication that works by targeting certain cells in the immune system. It is used to modify the body’s immune response in cases where the immune system may be attacking the body’s own tissues. In this trial, it is being studied to help restore ovarian function in women whose immune system may be affecting their ovaries. The medication is given through an intravenous infusion (through a vein) and works by reducing specific types of immune cells called B cells.

Investigated diseases:

Autoimmune Premature Ovarian Insufficiency – A condition where the immune system mistakenly attacks the ovaries, causing them to stop working properly before the age of 40. The disorder leads to irregular or absent menstrual periods and reduced fertility. Women with this condition experience a decrease in estrogen production and elevated levels of follicle-stimulating hormone (FSH). The ovaries stop releasing eggs regularly, making natural conception difficult. The condition can develop gradually or suddenly, and it affects the normal functioning of the reproductive system.

Trial ID:
2025-522133-66-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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