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

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

14 criteria

  • 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
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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.

What is already known about the treatment

Rituximab - A monoclonal antibody medication administered through intravenous infusion that specifically targets B-cells in the immune system. This medication is well-established in medical practice and extensively documented in medical literature, primarily used in treating autoimmune conditions and certain types of blood cancers. In autoimmune Premature Ovarian Insufficiency (POI) treatment, it works by depleting B-lymphocytes that may be involved in the autoimmune attack on ovarian tissue, potentially helping to restore normal ovarian function. Rituximab belongs to the pharmacological class of targeted immunotherapy agents and operates by binding to the CD20 protein found on B-cells, leading to their destruction and thereby reducing the autoimmune response.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522133-66-00Estimated enrolment30 patientsSponsorKarolinska University Hospital

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