Immunomodulatory Therapy in Women With Autoimmune Premature Ovarian Insufficiency
NCT ID: NCT05586737
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2019-04-29
2024-12-15
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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rituximab
Controlled ovarian hyperstimulation will be performed before and four months after two infusions of 1-gram rituximab (Mabthera®).
Rituximab
1 gram rituximab twice with two weeks interval
Interventions
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Rituximab
1 gram rituximab twice with two weeks interval
Eligibility Criteria
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Inclusion Criteria
2. 18-35 yrs of age
3. Body mass index 19-30.
4. In fertile females, willingness to comply with effective contraceptive methods.
5. Ability to provide informed consent
Exclusion Criteria
2. Active, severe infection
3. Severe immunosuppression
4. Severe cardiac disease
5. Cancer
6. Benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst
7. Vaginal bleeding of unknown aetiology
8. Hormone replacement therapy (HRT) within four weeks prior study entry.
9. Pregnant or lactating women
10. Concurrent treatment with other immunosuppressive drugs
11. Vaccination within 4 weeks of infusion of study medication
12. Severe psychiatric disorder
13. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with Rituximab.
18 Years
35 Years
FEMALE
No
Sponsors
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Angelica Lindén Hirschberg
OTHER
Responsible Party
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Angelica Lindén Hirschberg
Professor
Principal Investigators
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Olle Kämpe, MD, PhD
Role: STUDY_CHAIR
Karolinska Institutet
Locations
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Angelica Hirshberg
Stockholm, , Sweden
Countries
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Other Identifiers
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KarolinskaUniversityHospital
Identifier Type: -
Identifier Source: org_study_id