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

  • STATUS
    Recruiting
  • End date
    Dec 23, 2024
  • participants needed
    15
  • sponsor
    Angelica Lindén Hirschberg
Updated on 23 October 2022
body mass index
cancer
rituximab

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.

Details
Condition Autoimmune Diseases, Premature Ovarian Insufficiency
Treatment Rituximab
Clinical Study IdentifierNCT05586737
SponsorAngelica Lindén Hirschberg
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Autoimmune premature ovarian insufficiency defined as presence of autoantibodies against 21-OH, SCC, 17-OH and/or NALP5 or other relevant autoantibodies
18-35 yrs of age
Body mass index 19-30
In fertile females, willingness to comply with effective contraceptive methods
Ability to provide informed consent

Exclusion Criteria

Documented hypersensitivity or intolerance to rituximab
Active, severe infection
Severe immunosuppression
Severe cardiac disease
Cancer
Benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst
Vaginal bleeding of unknown aetiology
Hormone replacement therapy (HRT) within four weeks prior study entry
Pregnant or lactating women
Concurrent treatment with other immunosuppressive drugs
Vaccination within 4 weeks of infusion of study medication
Severe psychiatric disorder
Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with Rituximab
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