This study is testing whether finerenone, a medicine currently used to protect the kidneys and heart, can help women with premature ovarian insufficiency (POI) grow ovarian follicles and produce eggs that can be collected for in vitro fertilization (IVF). Women with POI often have very few or no active egg-containing follicles, making it hard for them to conceive. About 46 women with POI will be randomly assigned, without either the participants or their doctors knowing the assignment, to take either finerenone or a matching placebo twice weekly for 24 weeks. Participants will be monitored regularly with ultrasound and blood tests. If follicle growth is observed, participants may undergo ovarian stimulation so that eggs or embryos can be collected and frozen. The main goal is to see whether more women in the finerenone group have eggs successfully retrieved during an IVF cycle, compared with the placebo group. The study will also look at other measures of ovarian reserve, egg and embryo quality, and pregnancy outcomes among participants who go on to embryo transfer.
Age of women <40 years.
Oligomenorrhea or amenorrhea for at least 4 months; and
Elevated FSH levels (≥25 mIU/mL) on a single measurement.
Known hypersensitivity to Finerenone or any of its excipients.
Severe uncontrolled systemic diseases (cardiovascular, hepatic, renal, or endocrine disorders) that may interfere with study participation.
Active malignancy or history of hormone-dependent cancer.
Currently participating in another interventional trial.
Parallel
Finerenone
DrugFinerenone 20 mg oral tablet, administered twice weekly for 24 weeks.
Placebo
DrugMatching placebo tablet, oral, administered twice weekly for 24 weeks.
Proportion of Participants with Oocytes Retrieved During IVF Within 24 Weeks of Treatment
The proportion of participants who have oocytes aspirated during in vitro fertilization (IVF) within 24 weeks of starting study treatment.
Antral Follicle Count (AFC)
Change in antral follicle count (AFC) measured by ultrasound from baseline, assessed during follow-up visits.
Anti-Mullerian Hormone (AMH)
Change in serum Anti-Mullerian Hormone (AMH) level from baseline, assessed during follow-up visits.
Serum Estradiol (E2) Level on Trigger Day
Serum estradiol (E2) level measured on the day of ovulation trigger during follicular development monitoring.
Number of Total and Mature Oocytes Retrieved
Number of total oocytes and number of mature (MII) oocytes retrieved during IVF oocyte retrieval.
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This trial is not recruiting at the moment. You can still explore other options:
