Finerenone for Premature Ovarian Insufficiency (POI)

Condition(s) studied

Investigational drug(s) / intervention(s)

Finerenone: Finerenone 20 mg oral tablet, administered twice weekly for 24 weeks.

Placebo: Matching placebo tablet, oral, administered twice weekly for 24 weeks.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Proportion of Participants with Oocytes Retrieved During IVF Within 24 Weeks of Treatment — Within 24 weeks of treatment initiation
  The proportion of participants who have oocytes aspirated during in vitro fertilization (IVF) within 24 weeks of starting study treatment.

Trial sites (1)

More The University of Hong Kong-Shenzhen Hospital trials in China

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