Premature Ovarian Insufficiency
Conditions
Keywords
Finerenone, Ovarian Reserve, In Vitro Fertilization, Antral Follicle Count, Premature Ovarian Insufficiency
Brief 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.
Interventions
DRUGFinerenone
Finerenone 20 mg oral tablet, administered twice weekly for 24 weeks.
DRUGPlacebo
Matching placebo tablet, oral, administered twice weekly for 24 weeks.
Sponsors
The University of Hong Kong-Shenzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antral Follicle Count (AFC) | Baseline and every 4 weeks up to 24 weeks of treatment | Change in antral follicle count (AFC) measured by ultrasound from baseline, assessed during follow-up visits. |
| Anti-Mullerian Hormone (AMH) | Baseline and every 4 weeks up to 24 weeks of treatment | Change in serum Anti-Mullerian Hormone (AMH) level from baseline, assessed during follow-up visits. |
| Serum Estradiol (E2) Level on Trigger Day | On the day of ovulation trigger, within 24 weeks of treatment | Serum estradiol (E2) level measured on the day of ovulation trigger during follicular development monitoring. |
| Number of Total and Mature Oocytes Retrieved | At oocyte retrieval, within 24 weeks of treatment | Number of total oocytes and number of mature (MII) oocytes retrieved during IVF oocyte retrieval. |
| Fertilization Rate | Within 24 weeks of treatment initiation | Proportion of retrieved oocytes that are successfully fertilized during IVF. |
| Number of Embryos Formed | Within 24 weeks of treatment initiation | Number of embryos formed following fertilization of retrieved oocytes. |
| Blastocyst Development Rate / High-Quality Embryo Rate | Within 24 weeks of treatment initiation | Proportion of embryos developing to blastocyst stage and/or classified as high-quality embryos. |
| Clinical Pregnancy Rate | Approximately 6-7 weeks of gestation | Proportion of participants with ultrasound-confirmed intrauterine gestational sac at approximately 6-7 weeks of gestation following embryo transfer. |
| Ongoing Pregnancy Rate | 8-10 weeks of gestation | Proportion of participants with fetal cardiac activity confirmed by ultrasound at 8-10 weeks of gestation. |
| Live Birth Rate | At delivery (approximately 24-40 weeks gestation) | Proportion of participants with delivery at or beyond 24 weeks gestation. |
Countries
China
Contacts
CONTACTTianren Wang
Outcome results
None listed