A clinical trial investigating the effect of the drug rituximab on the fertility of women undergoing in vitro fertilization diagnosed with premature ovarian insufficiency due to an autoimmune conditio

Phase 1

• Conditions: Autoimmune premature ovarian insufficiency; MedDRA version: 20.0Level: LLTClassification code 10052660Term: Hypergonadotropic hypogonadismSystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-004532-10-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-10
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Autoimmune premature ovarian insufficiency defined as presence of autoantibodies against 21-OH, SCC, 17-OH and/or NALP5 or other relevant autoantibodies
2. 18-35 years of age
3. body mass index 19-30
4. Willingness to comply with effective non-hormonal contraceptive methods upto 12 months after the last infusion
5. Ability to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Documented hypersensitivity or intolerance to rituximab
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, s-HCG/u-HCG
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified