Actively Recruiting
Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency
Led by Angelica Lindén Hirschberg · Updated on 2026-04-03
40
Participants Needed
2
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Given written consent to participate in the trial
- Diagnosed with autoimmune POI with FSH > 25 IU/L confirmed twice at least 4 weeks apart
- Presence of oligo/amenorrhea lasting at least 4 months
- Have Addison's disease or tested positive for 21-hydroxylase or other relevant autoantibodies
- Aged 18 to 38 years
- Body mass index between 19 and 30
- Willing to use effective non-hormonal contraception during the 18-month study period
You will not qualify if you...
- Known hypersensitivity to rituximab, any AxMPs, or excipients
- Active, severe infection or JCV positivity
- Active hepatitis B infection
- Severe immunosuppression
- Severe cardiac disease
- Cancer
- Benign tumors of the hypothalamus, pituitary, or ovarian pathology
- Vaginal bleeding of unknown cause
- Hormone replacement therapy within 4 weeks before study entry
- Pregnant or breastfeeding
- Concurrent treatment with other immunosuppressive drugs
- Vaccination within 4 weeks before infusion of study medication
- Severe psychiatric disorder
- Any condition making treatment unsafe per investigator
- Active thrombolic disorder (contraindicated for Ovirelle)
- Moderate or severe kidney or liver impairment (contraindicated for Orgalutran)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, Sweden, 171 76
Actively Recruiting
2
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
Research Team
A
Angelica Lindén Hirschberg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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