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Completed

NCT Number: NCT05586737

Immunomodulatory Therapy in Women With Autoimmune Premature Ovarian Insufficiency

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.

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Key information

Conditions

Autoimmune Diseases Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Immune System Diseases Ovarian Diseases Premature Ovarian Insufficiency Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Angelica Hirshberg

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Drug

1 gram rituximab twice with two weeks interval

Primary outcomes

  1. Number of antral follicles in response to ovarian stimulation 4 months after last rituximab infusion.

    Time frame: 4 months

    Vaginal ultrasound measurement

  2. The largest follicle in response to ovarian stimulation 4 months after last rituximab infusion.

    Time frame: 4 months

    Vaginal ultrasound measurement

Secondary outcomes

  1. Spontaneous menstrual bleedings during the 12 months' study period

    Time frame: 12 months

    Number of spontaneous menstrual bleedings

  2. Ovulation during the 12 months' study period

    Time frame: 12 months

    Confirmed ovulation (y/n)

  3. Immunoglobulin levels

    Time frame: 4 and 12 months

    Change in immunoglobulin levels (g/L) from baseline

Sponsors and collaborators

Lead sponsor

Angelica Lindén Hirschberg

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2022
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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