[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655469":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":55,"interventions":66,"overallOfficials":48,"centralContacts":74,"locations":83,"responsibleParty":99,"collaborators":103,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":48,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":48,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":48,"overallStatus":165,"whyStopped":48,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"RenJi Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Good birth outcome rate","good birth outcome is defined as live birth(s) at ≥37 weeks, with infant birth weight between 2500 and 4000g and without a major congenital anomaly.","at delivery",[14,18,22,25,29,32,35,39,42,45],{"measure":15,"description":16,"timeFrame":17},"Biochemical pregnancy rate","biochemical pregnancy is defined as serum beta-human chorionic gonadotropin (β-hCG) ≥10 mIU\u002Fml.","12-17 days after frozen embryo transfer",{"measure":19,"description":20,"timeFrame":21},"Clinical pregnancy rate","clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac.","28-35 days after frozen embryo transfer",{"measure":23,"description":24,"timeFrame":21},"Implantation rate","implantation rate is calculated as the number of gestational sacs by a transvaginal ultrasound scan\u002Fnumber of embryos transferred.",{"measure":26,"description":27,"timeFrame":28},"Pregnancy loss rate","pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.","From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months",{"measure":30,"description":31,"timeFrame":12},"Live birth rate","live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.",{"measure":33,"description":34,"timeFrame":12},"Gestational weight gain","maternal weight gain during pregnancy.",{"measure":36,"description":37,"timeFrame":38},"Incidences of obstetric and neonatal complications","including gestational diabetes mellitus, pre-eclampsia, placenta previa, placental abruption, congenital anomalies, postpartum hemorrhage, preterm birth, neonatal respiratory distress syndrome, neonatal jaundice, neonatal infection, neonatal death, etc.","From the establishment of clinically recognized pregnancy until six weeks after delivery",{"measure":40,"description":41,"timeFrame":38},"Incidence of composite endpoint of obesity-related pregnancy complications","composite incidences of miscarriage, gestational diabetes mellitus, hypertensive disorders of pregnancy, and preterm birth.",{"measure":43,"description":44,"timeFrame":12},"Birth weight","birth weight of the newborn at delivery.",{"measure":46,"description":47,"timeFrame":38},"Incidence of congenital anomalies","congenital malformations or birth defects.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":48},"NONE",[56,62],{"label":57,"type":58,"description":59,"interventionNames":60},"Delayed FET","EXPERIMENTAL","Participants will receive 16-week tirzepatide pretreatment prior to FET alongside lifestyle modification guidance, with a target weight loss of 10%-15% of total body weight.",[61],"Drug: Dual GIP\u002FGLP-1 receptor agonist",{"label":63,"type":64,"description":65,"interventionNames":48},"Standard FET","NO_INTERVENTION","Participants will receive lifestyle modification guidance and proceed to FET with no predefined weight-loss target.",[67],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"DRUG","Dual GIP\u002FGLP-1 receptor agonist","16 weeks treatment",[57],[73],"Tirzepatide",[75,80],{"name":76,"role":77,"phone":78,"phoneExt":48,"email":79},"Yun Sun, Professor","CONTACT","+86 20284574","sunyun_rj@163.com",{"name":81,"role":77,"phone":78,"phoneExt":48,"email":82},"Yao Lu","yaoluinrenji@163.com",[84],{"facility":5,"status":48,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Shanghai","Shanghai Municipality","200025","China","CN",{"type":91,"coordinates":92},"Point",[93,94],121.45806,31.22222,{"lat":94,"lon":93},[97,98],{"name":76,"role":77,"phone":78,"phoneExt":48,"email":79},{"name":81,"role":77,"phone":78,"phoneExt":48,"email":82},{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"PRINCIPAL_INVESTIGATOR","Yun Sun","Professor",[104,106,108,111,113,115,117,119,121,123,125,128,130,133,135,137,139,141,143],{"name":105,"class":6},"Shandong University",{"name":107,"class":6},"Shanghai Zhongshan Hospital",{"name":109,"class":110},"Shenyang Women's and Children's Hospital","UNKNOWN",{"name":112,"class":6},"Third Affiliated Hospital of Zhengzhou University",{"name":114,"class":6},"Henan Provincial People's Hospital",{"name":116,"class":6},"The Second Hospital of Hebei Medical University",{"name":118,"class":6},"Jiangsu Provincial People's Hospital",{"name":120,"class":6},"Shanghai First Maternity and Infant Hospital",{"name":122,"class":6},"West China Second University Hospital",{"name":124,"class":6},"Nanjing Maternity and Child Health Care Hospital",{"name":126,"class":127},"Anhui Provincial Hospital","OTHER_GOV",{"name":129,"class":6},"Northwest Women's and Children's Hospital, Xi'an, Shaanxi",{"name":131,"class":132},"Shenyang Jinghua Hospital","INDUSTRY",{"name":134,"class":6},"The First Affiliated Hospital of Anhui Medical University",{"name":136,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":138,"class":6},"Tongji Hospital",{"name":140,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"name":142,"class":6},"Tianjin Central Hospital of Gynecology Obstetrics",{"name":144,"class":6},"Ningbo Women & Children's Hospital","100655469","dual-gipglp-1-receptor-agonist-in-obese-women-before-frozen-embryo-transfer-100655469",false,"NCT07811895","Dual GIP\u002FGLP-1 Receptor Agonist in Obese Women Before Frozen Embryo Transfer","Dual Glucose-dependent Insulinotropic Peptide (GIP) and Glucagon-like Peptide-1 (GLP-1) Receptor Agonist in Women With Obesity for Frozen Embryo Transfer (FET): Pragmatic, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Women aged 20-40 years;\n2. Body Mass Index(BMI) ≥ 28kg\u002Fm2;\n3. Women who intend to undergo frozen-thawed embryo transfer;\n4. At least one embryo available for transfer;\n5. Be capable of giving informed consent.\n\nExclusion Criteria:\n\n1. Women who have been diagnosed with diseases affecting uterine cavity or endometrial receptivity;\n2. Presence of endocrine disorders that may significantly affect body weight;\n3. Use of drugs that may cause significant weight changes within 8 weeks before screening;\n4. Presence of contraindications to the use of dual GIP\u002FGLP-1 receptor agonist;\n5. Previous bariatric surgery (e.g., gastric bypass) or planning to undergo such surgery during the study period;\n6. Serum triglycerides (TG) \\> 5.64mmol\u002FL;\n7. Calcitonin≥50 ng\u002FL;\n8. Presence of medical contraindications to assisted reproductive technology and\u002For pregnancy;\n9. Any other condition considered inappropriate for participation by the investigator.","FEMALE","20 Years","40 Years",{"count":156,"type":157},1510,"ESTIMATED","INTERVENTIONAL",[160],"NA","To evaluate the efficacy and safety of Dual GIP\u002FGLP-1 receptor agonist pretreatment on reproductive outcomes in obese women before frozen embryo transfer.",[73,163,164],"Frozen Embryo Transfer","Obesity","NOT_YET_RECRUITING","2026-09-03",{"date":168,"type":169},"2026-09-10","ACTUAL",{"date":171,"type":157},"2026-09",{"date":173,"type":157},"2030-12",{"name":5,"class":6},1]