Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency

Sponsor
Angelica Lindén Hirschberg
Study ID
NCT07509840
Phase
PHASE3
Status
Recruiting
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Conditions

  • Autoimmune Prematur Ovarian Insuffience

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 38 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Several autoimmune diseases such as Addison's disease are associated with failing ovarian function, known as premature ovarian insufficiency (POI), which can lead to early menopause and reduced fertility.The underlying cause of POI in these women is considered to be an immunological attack on the ovaries that causes them to not respond to hormonal stimulation from the brain. Hormone replacement effectively counteracts menopausal symptoms, but today there is no treatment to normalize or even improve fertility. As a patient with POI and an autoimmune diagnosis and the desire to become pregnant, you are asked to participate in the study. The aim of this study is to investigate whether immunomodulatory therapy can improve and ideally normalize ovarian function in women of childbearing age with autoimmune disease and proven POI. Patients with a male partner and a desire for children and who respond positively to the first ovarian stimulation will be offered in vitro fertilization (IVF) and will thus be allowed to complete the study. Other participating patients will undergo a total of three ovarian stimulations and treatment with first two infusions of the registered drug rituximab or placebo (inactive agent) and later two additional infusions where all patients receive rituximab. The first two infusions with rituximab or placebo are double-blind, which means that neither you nor the study staff know what you have received. Follow-up takes place up to 12 months after the last infusion.

Key Dates

Start date
Feb 12, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A 2 infusions with placebo or Rituximab, and then 2 infusions of Rituximab
    Randomized to 2 infusions of placebo or Rituximab (2g) with a 2-week interval between infusions 1 and 2 , and then 2 infusions of Rituximax (2g) ,after a 6-month interval between the first two and the last two infusions.
  • Active Comparator: Group B , 2 infusions (2 g) Rituximab
    Group B a total of 2 infusions (2 g) with Rituximab, 2 weeks apart per occasion.

Primary Outcome Measure

Egg retrieval in response to controlled ovarian hyperstimulation [ Time Frame: 4 to 6 months after rituximab/placebo treatment. ]

Central Contacts