NCT05586737

Immunomodulatory Therapy in Women With Autoimmune Premature Ovarian Insufficiency

Effects of Immunomodulatory Therapy on Gonadal Function in Women With Autoimmune Premature Ovarian Insufficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Angelica Lindén Hirschberg · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autoimmune Diseases
• Premature Ovarian Insufficiency

Interventions

Type	Name	Description
DRUG	Rituximab	1 gram rituximab twice with two weeks interval

Timeline

• Start date: 2019-04-29
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2022-10-19
• Last updated: 2024-12-18

Locations

1 site across 1 country: Sweden