Immunomodulatory Therapy in Women With Autoimmune Premature Ovarian Insufficiency
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Title: Effects of immunomodulatory therapy on gonadal function in women with autoimmune
premature ovarian insufficiency (POI)
Trial objectives and purpose: To study if rituximab therapy can improve ovarian response to
gonadotropin stimulation and menstrual function in women with autoimmune POI.
Treatment: Controlled ovarian hyperstimulation before and four months after an infusion of
1-gram rituximab (Mabthera®) twice with two weeks interval. Follow-up period 12 months after
infusion.
Primary outcome: Number of antral follicles and the size of the largest follicle in response
to ovarian stimulation.
Secondary outcomes:
1. Reestablishment of spontaneous menstrual bleedings during the 12 months' study period
2. Ovulation during the 12 months' study period
3. Change in B-cell count, autoantibody indices and immunoglobulin levels (IgG) after
treatment
Safety outcomes: All adverse events. Of particular relevance are any hospital admissions,
infections and allergic reactions.
Study population: Fifteen women with autoimmune POI defined as absence of menstruation > 6
months and elevated serum level of follicle stimulation hormone > 40 International units
(IU)/L.
Inclusion criteria: Autoimmune POI defined as presence of autoantibodies against
21-hydroxylase (OH), side chain cleavage enzyme (SCC), 17-OH and/or neuronal apoptosis
inhibitory protein (NACHT) leucine-rich-repeat protein 5 (NALP5) or other relevant
autoantibodies; 18-35 yrs of age; body mass index 19-30.
Exclusion criteria: Hypersensitivity to rituximab; severe infection; severe
immunosuppression; cardiac disease; cancer; benign tumours of the hypothalamus, pituitary, or
ovary; ovarian enlargement or ovarian cyst; vaginal bleeding of unknown aetiology.
Time plan: The study is expected to start the spring 2017. It is expected to be closed spring
2023.