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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
Finerenone 20 mg oral tablet, administered twice weekly for 24 weeks.
Matching placebo tablet, oral, administered twice weekly for 24 weeks.
The University of Hong Kong Shenzhen Hospital
Shenzhen, Guangdong, China
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.
Time frame: Within 24 weeks of treatment initiation
Antral Follicle Count (AFC)
Change in antral follicle count (AFC) measured by ultrasound from baseline, assessed during follow-up visits.
Time frame: Baseline and every 4 weeks up to 24 weeks of treatment
Anti-Mullerian Hormone (AMH)
Change in serum Anti-Mullerian Hormone (AMH) level from baseline, assessed during follow-up visits.
Time frame: Baseline and every 4 weeks up to 24 weeks of treatment
Serum Estradiol (E2) Level on Trigger Day
Serum estradiol (E2) level measured on the day of ovulation trigger during follicular development monitoring.
Time frame: On the day of ovulation trigger, within 24 weeks of treatment
Number of Total and Mature Oocytes Retrieved
Number of total oocytes and number of mature (MII) oocytes retrieved during IVF oocyte retrieval.
Time frame: At oocyte retrieval, within 24 weeks of treatment
Fertilization Rate
Proportion of retrieved oocytes that are successfully fertilized during IVF.
Time frame: Within 24 weeks of treatment initiation
Number of Embryos Formed
Number of embryos formed following fertilization of retrieved oocytes.
Time frame: Within 24 weeks of treatment initiation
Blastocyst Development Rate / High-Quality Embryo Rate
Proportion of embryos developing to blastocyst stage and/or classified as high-quality embryos.
Time frame: Within 24 weeks of treatment initiation
Clinical Pregnancy Rate
Proportion of participants with ultrasound-confirmed intrauterine gestational sac at approximately 6-7 weeks of gestation following embryo transfer.
Time frame: Approximately 6-7 weeks of gestation
Ongoing Pregnancy Rate
Proportion of participants with fetal cardiac activity confirmed by ultrasound at 8-10 weeks of gestation.
Time frame: 8-10 weeks of gestation
Live Birth Rate
Proportion of participants with delivery at or beyond 24 weeks gestation.
Time frame: At delivery (approximately 24-40 weeks gestation)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.