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 condition

Effects of immunomodulatory therapy on gonadal function in women with autoimmune premature ovarian insufficiency

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004532-10-SE

Enrollment

Unknown

Registered

2018-01-10

Start date

2018-05-23

Completion date

Unknown

Last updated

2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune premature ovarian insufficiency MedDRA version: 20.0 Level: LLT Classification code 10052660 Term: Hypergonadotropic hypogonadism System Organ Class: 100000004860

Interventions

Trade Name: Mabthera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 •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.	—

Measure

Time frame

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 •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.

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Secondary

Measure	Time frame
Secondary end point(s): Mid assessment at month 2 and 8: blood sample, pregnancy test, vital signs and adverse events. Post treatment assessment at month 4: blood sample, pregnancy test, gynecological assessment with ultrasound, controlled ovarian hyperstimulation, vital signs and adverse events. 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 Post treatment assessment at month 4 End assessment at month 12	—

Measure

Time frame

Secondary end point(s): Mid assessment at month 2 and 8: blood sample, pregnancy test, vital signs and adverse events. Post treatment assessment at month 4: blood sample, pregnancy test, gynecological assessment with ultrasound, controlled ovarian hyperstimulation, vital signs and adverse events. 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 Post treatment assessment at month 4 End assessment at month 12

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Countries

Sweden

Contacts

Public ContactDepartment of Molecular Medicine

Karolinska University Hospital

sigridur.bjornsdottir@karolinska.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026