Effects of Immunomodulatory Therapy on Gonadal Function in Women With Autoimmune Premature Ovarian Insufficiency
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- STATUS
- Recruiting
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- End date
- Dec 23, 2024
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- participants needed
- 15
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- sponsor
- Angelica Lindén Hirschberg
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:
- Reestablishment of spontaneous menstrual bleedings during the 12 months' study period
- Ovulation during the 12 months' study period
- 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.
Details
| Condition | Autoimmune Diseases, Premature Ovarian Insufficiency |
|---|---|
| Treatment | Rituximab |
| Clinical Study Identifier | NCT05586737 |
| Sponsor | Angelica Lindén Hirschberg |
| Last Modified on | 23 October 2022 |
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