[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655639":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":50,"studyPopulation":50,"armGroups":62,"interventions":75,"overallOfficials":50,"centralContacts":83,"locations":89,"responsibleParty":106,"collaborators":50,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":50,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":50,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":132,"whyStopped":50,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"The University of Hong Kong-Shenzhen Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Within 24 weeks of treatment initiation",[14,18,21,25,29,32,35,38,42,46],{"measure":15,"description":16,"timeFrame":17},"Antral Follicle Count (AFC)","Change in antral follicle count (AFC) measured by ultrasound from baseline, assessed during follow-up visits.","Baseline and every 4 weeks up to 24 weeks of treatment",{"measure":19,"description":20,"timeFrame":17},"Anti-Mullerian Hormone (AMH)","Change in serum Anti-Mullerian Hormone (AMH) level from baseline, assessed during follow-up visits.",{"measure":22,"description":23,"timeFrame":24},"Serum Estradiol (E2) Level on Trigger Day","Serum estradiol (E2) level measured on the day of ovulation trigger during follicular development monitoring.","On the day of ovulation trigger, within 24 weeks of treatment",{"measure":26,"description":27,"timeFrame":28},"Number of Total and Mature Oocytes Retrieved","Number of total oocytes and number of mature (MII) oocytes retrieved during IVF oocyte retrieval.","At oocyte retrieval, within 24 weeks of treatment",{"measure":30,"description":31,"timeFrame":12},"Fertilization Rate","Proportion of retrieved oocytes that are successfully fertilized during IVF.",{"measure":33,"description":34,"timeFrame":12},"Number of Embryos Formed","Number of embryos formed following fertilization of retrieved oocytes.",{"measure":36,"description":37,"timeFrame":12},"Blastocyst Development Rate \u002F High-Quality Embryo Rate","Proportion of embryos developing to blastocyst stage and\u002For classified as high-quality embryos.",{"measure":39,"description":40,"timeFrame":41},"Clinical Pregnancy Rate","Proportion of participants with ultrasound-confirmed intrauterine gestational sac at approximately 6-7 weeks of gestation following embryo transfer.","Approximately 6-7 weeks of gestation",{"measure":43,"description":44,"timeFrame":45},"Ongoing Pregnancy Rate","Proportion of participants with fetal cardiac activity confirmed by ultrasound at 8-10 weeks of gestation.","8-10 weeks of gestation",{"measure":47,"description":48,"timeFrame":49},"Live Birth Rate","Proportion of participants with delivery at or beyond 24 weeks gestation.","At delivery (approximately 24-40 weeks gestation)",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":57},"QUADRUPLE",[58,59,60,61],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[63,69],{"label":64,"type":65,"description":66,"interventionNames":67},"Finerenone","EXPERIMENTAL","Participants received oral finerenone 20 mg twice weekly for 24 weeks during the double-blind treatment phase.",[68],"Drug: Finerenone",{"label":70,"type":71,"description":72,"interventionNames":73},"Placebo","PLACEBO_COMPARATOR","Participants received matching placebo tablets, oral, twice weekly for 24 weeks during the double-blind treatment phase.",[74],"Drug: Placebo",[76,80],{"type":77,"name":64,"description":78,"armGroupLabels":79,"otherNames":50},"DRUG","Finerenone 20 mg oral tablet, administered twice weekly for 24 weeks.",[64],{"type":77,"name":70,"description":81,"armGroupLabels":82,"otherNames":50},"Matching placebo tablet, oral, administered twice weekly for 24 weeks.",[70],[84],{"name":85,"role":86,"phone":87,"phoneExt":50,"email":88},"Tianren Wang","CONTACT","+85222554684","wangtr@hku.hk",[90],{"facility":91,"status":50,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"The University of Hong Kong Shenzhen Hospital","Shenzhen","Guangdong","518000","China","CN",{"type":98,"coordinates":99},"Point",[100,101],114.0683,22.54554,{"lat":101,"lon":100},[104],{"name":85,"role":86,"phone":87,"phoneExt":50,"email":105},"wtrcmu@126.com",{"type":107,"investigatorFullName":85,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Clinical Assistant Professor","100655639","phase-2-finerenone-for-premature-ovarian-insufficiency-poi-100655639",false,"NCT07815509","Finerenone for Premature Ovarian Insufficiency (POI)","A Randomized, Double-Blind, Placebo-Controlled Trial of Finerenone in Women With Premature Ovarian Insufficiency","Inclusion Criteria:\n\n* Age of women \\\u003C40 years.\n* Diagnosis of POI according to ESHRE 2024 guidelines, defined as:\n* Oligomenorrhea or amenorrhea for at least 4 months; and\n* Elevated FSH levels (≥25 mIU\u002FmL) on a single measurement.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Finerenone or any of its excipients.\n* Severe uncontrolled systemic diseases (cardiovascular, hepatic, renal, or endocrine disorders) that may interfere with study participation.\n* Active malignancy or history of hormone-dependent cancer.\n* Currently participating in another interventional trial.\n* Known chromosomal abnormalities or clinically significant genetic syndromes associated with POI.","FEMALE","18 Years","39 Years",{"count":120,"type":121},46,"ESTIMATED","INTERVENTIONAL",[124],"PHASE2","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.",[127],"Premature Ovarian Insufficiency",[64,129,130,131,127],"Ovarian Reserve","In Vitro Fertilization","Antral Follicle Count","NOT_YET_RECRUITING","2026-09-08",{"date":135,"type":136},"2026-09-11","ACTUAL",{"date":138,"type":121},"2026-09-15",{"date":140,"type":121},"2028-09",{"name":5,"class":6},1]