Finerenone for Premature Ovarian Insufficiency (POI)

A Randomized, Double-Blind, Placebo-Controlled Trial of Finerenone in Women With Premature Ovarian Insufficiency

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.

Inclusion Criteria:

• Age of women <40 years.
• Diagnosis of POI according to ESHRE 2024 guidelines, defined as:
• Oligomenorrhea or amenorrhea for at least 4 months; and
• Elevated FSH levels (≥25 mIU/mL) on a single measurement.

Exclusion Criteria:

• 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.
• Known chromosomal abnormalities or clinically significant genetic syndromes associated with POI.