[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601791":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":52,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":26,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Changhai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Climen","ACTIVE_COMPARATOR","Hormone replacement therapy (HRT): Take the drug Climen. Each box has 21 tablets. The first 11 tablets contain 2 milligrams of estradiol valerate each. The last 10 tablets contain 2 milligrams of estradiol valerate and 1 milligram of cyproterone acetate each. Begin taking it on the fifth day of your menstrual cycle. Take one tablet every day for seven days. Then, stop taking the medicine for seven days. After that, continue for two cycles in a row.",[13],"Drug: Climen 21 Tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"hA-MSCs+Climen","EXPERIMENTAL","The stem cell treatment group will be administered Climen, with the dosage and method of administration to be determined based on the control group. Concurrently, patients will receive the initial infusion of amniotic MSCs intravenously on the third day after the onset of menstruation, with a subsequent infusion administered after one month. The number of stem cells infused was calculated according to 1 million cells per kilogram of body weight.",[13,19],"Biological: hA-MSCs",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Climen 21 Tablets","Climen is commonly used clinically as a hormone replacement therapy and was administered to all patients in both the control and experimental groups in this project.",[9,15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BIOLOGICAL","hA-MSCs","The patients who were part of the experimental group were administered oral Clomid medication in conjunction with a combined intravenous injection of human amniotic MSCs.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Hongli Yan PhD, Professor, Reproductive Medici","CONTACT","021-31162338","hongliyan@smmu.edu.cn",[39],{"facility":40,"status":41,"city":42,"state":26,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":26},"Shanghai Changhai Hospital","RECRUITING","Shanghai","200433","China","CN",{"type":47,"coordinates":48},"Point",[49,50],121.45806,31.22222,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Yan Hongli","Professor of Reproductive Medicine","100601791","phase-1-clinical-study-on-the-safety-and-efficacy-of-human-amniotic-mesenchymal-stem-cells-in-the-treatment-of-premature-ovarian-insufficiency-100601791",false,"NCT07115082","Clinical Study on the Safety and Efficacy of Human Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency","A Randomized, Open-label, Parallel-controlled Clinical Study of Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency","Inclusion Criteria:\n\n1. The intention of pregnant women aged \\>= 20 and \\\u003C 40, with normal karyotype;\n2. Oligo\u002Famenorrhea for at least 4 months;\n3. Elevated FSH level \\>25 IU\u002Fl on two occasions \\>4 weeks apart;\n4. Without a history of stem cell therapy and no growth hormone and\u002For estrogen and progesterone therapy within the previous 3 months;\n5. Voluntary participation in the study with signed informed consent;\n\nExclusion Criteria:\n\n1. Unable to follow the treatment observation process required by the trial;\n2. Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency\u002Fpremature ovarian failure;\n3. With breast, uterine, ovarian tumors, or any other benign or malignant tumors;\n4. Allergic history to drugs or any other things;\n5. Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.\n6. Have undergone ovariectomy or have organic gynaecological diseases.\n7. Presence of other gynaecological endocrine diseases such as polycystic ovary syndrome.\n8. Severe functional impairment of vital organs.\n9. High risk factors for venous thromboembolism and abnormalities in coagulation mechanisms.\n10. Attending doctor considers inappropriate to take part in.","FEMALE","20 Years","40 Years",{"count":67,"type":68},50,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of human Amniotic mesenchymal stem cells (hA-MSCs) therapy in women suffering from POI.",[75],"Premature Ovarian Insufficiency",[29,77],"Premature ovarian insufficiency","2025-08-04",{"date":80,"type":81},"2025-08-11","ACTUAL",{"date":83,"type":81},"2024-10-15",{"date":85,"type":68},"2026-03-30",{"name":54,"class":6},1]