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The REFINE study
EU CTIS ID: 2025-522133-66-00
What this study is testing
The primary objective of this trial is to investigate the efficacy of rituximab in enabling egg retrieval after controlled ovarian hyperstimulation in autoimmune POI 4 to 6 months after rituximab compared to placebo, as well as the whole group treated with rituximab at 4 to 6 and 12 months after the last treatment session compared to baseline.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject has given their written consent to participate in the trial
- Autoimmune POI (FSH > 25 IU/L) including the presence of oligo/amenorrhea lasting at least 4 months, and elevated FSH levels (FSH > 25 IU/L) confirmed on two separate occasions, with measurements taken at least 4 weeks apart and Addison’s disease or ab positivity for 21-hydroxylase or other relevant autoantibodies (SCC, 17-OH, NALP5)
- 18-38 years of age
- Body mass index between 19-30
- Willing to use effective non-hormonal contraceptive method (such as intra uterine device (IUD), sexual abstinence, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) during the 18-month study period
You likely can't join if
- Hypersensitivity to rituximab, any of the AxMPs, or any of the excipients (as detailed in the SmPC for the various IMPs)
- Benign tumours of the hypothalamus, pituitary, or ovarian pathology
- Vaginal bleeding of unknown etiology
- Hormone replacement therapy within four weeks prior study entry
- Pregnant or lactating women
- Active hepatitis B infection
See the full eligibility criteria
- The subject has given their written consent to participate in the trial
- Autoimmune POI (FSH > 25 IU/L) including the presence of oligo/amenorrhea lasting at least 4 months, and elevated FSH levels (FSH > 25 IU/L) confirmed on two separate occasions, with measurements taken at least 4 weeks apart and Addison’s disease or ab positivity for 21-hydroxylase or other relevant autoantibodies (SCC, 17-OH, NALP5)
- 18-38 years of age
- Body mass index between 19-30
- Willing to use effective non-hormonal contraceptive method (such as intra uterine device (IUD), sexual abstinence, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) during the 18-month study period
- Hypersensitivity to rituximab, any of the AxMPs, or any of the excipients (as detailed in the SmPC for the various IMPs)
- Benign tumours of the hypothalamus, pituitary, or ovarian pathology
- Vaginal bleeding of unknown etiology
- Hormone replacement therapy within four weeks prior study entry
- Pregnant or lactating women
- Active hepatitis B infection
- Active thrombolic disorder (contraindicated for Ovirelle)
- Moderate or severe impairment of kidney or liver function (contraindicated for Orgalutran)
- Concurrent treatment with other immunosuppressive drugs
- Any vaccination within 4 weeks of infusion of study medication
- Severe psychiatric disorder
- Any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with rituximab or controlled ovarian hyperstimulation
- Active, severe infection or JCV positivity
- Severe immunosuppression
- Severe cardiac disease
- Cancer
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.