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NCT Number: NCT07815509

Finerenone for Premature Ovarian Insufficiency (POI)

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.

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Key information

Conditions

Premature Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The University of Hong Kong Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

Location contact

Tianren Wang

CONTACT

[email protected]

+85222554684

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Finerenone

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Proportion of Participants with Oocytes Retrieved During IVF Within 24 Weeks of Treatment

    Time frame: 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 outcomes

  1. Antral Follicle Count (AFC)

    Time frame: 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.

  2. Anti-Mullerian Hormone (AMH)

    Time frame: 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.

  3. Serum Estradiol (E2) Level on Trigger Day

    Time frame: 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.

  4. Number of Total and Mature Oocytes Retrieved

    Time frame: At oocyte retrieval, within 24 weeks of treatment

    Number of total oocytes and number of mature (MII) oocytes retrieved during IVF oocyte retrieval.

  5. Fertilization Rate

    Time frame: Within 24 weeks of treatment initiation

    Proportion of retrieved oocytes that are successfully fertilized during IVF.

  6. Number of Embryos Formed

    Time frame: Within 24 weeks of treatment initiation

    Number of embryos formed following fertilization of retrieved oocytes.

  7. Blastocyst Development Rate / High-Quality Embryo Rate

    Time frame: Within 24 weeks of treatment initiation

    Proportion of embryos developing to blastocyst stage and/or classified as high-quality embryos.

  8. Clinical Pregnancy Rate

    Time frame: 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.

  9. Ongoing Pregnancy Rate

    Time frame: 8-10 weeks of gestation

    Proportion of participants with fetal cardiac activity confirmed by ultrasound at 8-10 weeks of gestation.

  10. Live Birth Rate

    Time frame: At delivery (approximately 24-40 weeks gestation)

    Proportion of participants with delivery at or beyond 24 weeks gestation.

Study contacts

Contact information is provided by the study sponsor or research team.

Tianren Wang

CONTACT

[email protected]

+85222554684

Sponsors and collaborators

Lead sponsor

The University of Hong Kong-Shenzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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