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

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To study if rituximab therapy can improve ovarian response to gonadotropin stimulation in women with autoimmune POI. ;Secondary Objective: • To investigate if rituximab therapy can improve menstrual function and restore ovulation<br>•To study the immunological response by the treatment and AMH as a marker for the ovarian reserve ;Primary end point(s): Adverse events. Of particular relevance are any hospital admissions, infections and allergic reactions.;Timepoint(s) of evaluation of this end point: During the study period of one year for each patient.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Mid assessment at month 2 and 8: blood sample, pregnancy test, vital signs and adverse events.<br><br>Post treatment assessment at month 4: blood sample, pregnancy test, gynecological assessment with ultrasound, controlled ovarian hyperstimulation, vital signs and adverse events.<br><br>End assessment at month 12 : blood sample, pregnancy test, vital signs and adverse events.;Timepoint(s) of evaluation of this end point: Mid assessment at month 2 and 8<br><br>Post treatment assessment at month 4<br><br>End assessment at month 12

Related Trials