[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615746":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":56,"collaborators":58,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":27,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":27,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":120,"whyStopped":27,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Western medicine group","PLACEBO_COMPARATOR","Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.",[13,14],"Drug: Western Medicine","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Integrated traditional Chinese and Western medicine","EXPERIMENTAL","Take the \"Xiehe DOR Kidney-Tonifying Universal Formula\" orally for three months; thereafter, continue the Chinese herbal formula while combining it with three cycles of letrozole.",[13,20],"Drug: Traditional Chinese Medicine",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Western Medicine","Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).",[16,9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Traditional Chinese Medicine","\"Xiehe DOR Kidney-Tonifying Universal Formula\" is a traditional Chinese medicine (TCM) granule formulation prepared in-hospital. It is taken by dissolving one sachet in hot water, three times daily.",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Placebo","The appearance and packaging of the placebo are exactly the same as those of \"Xiehe DOR Kidney-Tonifying Universal Formula\". It is also taken by dissolving one sachet in hot water, three times daily.",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Yingying Guo, Doctor","CONTACT","86+010-69158331","guoyy28@gmail.com",[43],{"facility":44,"status":27,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":27},"Peking union medical college hospital","Beijing","Beijing Municipality","100730","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},{"type":57,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[59,61,63,65,67,69,71,73,75,77,79,81,83,85,88,90,92,94],{"name":60,"class":6},"Dongfang Hospital Beijing University of Chinese Medicine",{"name":62,"class":6},"Beijing University of Chinese Medicine",{"name":64,"class":6},"The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine",{"name":66,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"name":68,"class":6},"Hunan University of Traditional Chinese Medicine",{"name":70,"class":6},"Shandong University",{"name":72,"class":6},"Xiamen University",{"name":74,"class":6},"Beijing Obstetrics and Gynecology Hospital",{"name":76,"class":6},"Xiyuan Hospital of China Academy of Chinese Medical Sciences",{"name":78,"class":6},"The Third Affiliated Hospital of Beijing University of Chinese Medicine",{"name":80,"class":6},"Hunan Provincial Maternal and Child Health Care Hospital",{"name":82,"class":6},"Guangdong Provincial Hospital of Traditional Chinese Medicine",{"name":84,"class":6},"Affiliated Hospital of Shandong University of Traditional Chinese Medicine",{"name":86,"class":87},"Institute of Basic Medical Sciences CAMS","UNKNOWN",{"name":89,"class":6},"First Affiliated Hospital of Heilongjiang Chinese Medicine University",{"name":91,"class":87},"Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan)",{"name":93,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":95,"class":87},"Shenyang Women's and Children's Hospital","100615746","phase-3-clinical-evaluation-of-integrated-chinese-western-medicine-for-infertility-with-dor-patients-in-women-achieving-natural-pregnancy-100615746",false,"NCT07296614","Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in Women Achieving Natural Pregnancy","Integrative Chinese and Western Medicine for Diminished Ovarian Reserve-Associated Infertility in Natural Conception Population","Inclusion Criteria:\n\n1. Female patients aged 22 to 39 years (inclusive).\n2. Meet the diagnostic criteria for diminished ovarian reserve (requiring at least two of the following: Basal FSH 10-25 IU\u002FL; AMH \\\u003C 1.1 ng\u002FmL; AFC \\\u003C 7) and infertility(defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse).\n3. Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine\n4. Voluntarily participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients with premature ovarian insufficiency or premature ovarian failure (basal FSH \\>25 IU\u002FL), organic pathologies such as ovarian tumors, endometrial tuberculosis, intrauterine adhesions, or endometrial injuries, as well as those with congenital adrenal hyperplasia or Cushing's syndrome;\n2. Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc.\n3. Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards).\n4. DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy\u002Fchemotherapy, uterine artery embolization, etc.).\n5. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders.\n6. Individuals with known allergies to the investigational drug or its components.\n7. Use of hormonal medications (e.g., estrogen, contraceptive drugs) within one month prior to enrollment, or use of kidney-tonifying Chinese herbal medicines or proprietary Chinese medicinal products within one month prior to enrollment.\n8. Patients currently participating in or planning to participate in other clinical trials.","FEMALE","22 Years","39 Years",{"count":107,"type":108},320,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","This study aims to evaluate the superiority of an integrated traditional Chinese and Western medicine regimen (\"Xiehe DOR Bushen Tongzhi Formula\" + ovulation induction therapy with ovulation monitoring and timed intercourse) compared to standard treatment alone (placebo + ovulation induction therapy with ovulation monitoring and timed intercourse) in improving the natural cumulative clinical pregnancy rate in infertile patients with kidney deficiency-type diminished ovarian reserve (DOR).",[114,115],"Diminished Ovarian Reserve (DOR)","Infertility",[117,115,118,119],"Diminished ovarian reserve (DOR)","Integrated Traditional Chinese and Western Clinical Medicine","Randomized controlled trial","NOT_YET_RECRUITING","2025-12-18",{"date":123,"type":124},"2025-12-22","ACTUAL",{"date":126,"type":108},"2025-12-25",{"date":128,"type":108},"2028-07-30",{"name":5,"class":6},1]