[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521059":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":55,"centralContacts":59,"locations":65,"responsibleParty":84,"collaborators":87,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":63,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":63,"overallStatus":67,"whyStopped":63,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Shandong University","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin-Metformin Group","EXPERIMENTAL","Metformin pretreatment before ovarian stimulation till oocyte retrieval and cryopreservation of all embryos, and followed by metformin pretreatment before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.",[13,14],"Drug: Metformin pretreatment before ovarian stimulation","Drug: Metformin pretreatment before endometrial preparation for frozen embryo transfer",{"label":16,"type":10,"description":17,"interventionNames":18},"Metformin-Placebo Group","Metformin pretreatment before ovarian stimulation till oocyte retrieval and cryopreservation of all embryos, and followed by placebo pretreatment before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.",[13,19],"Drug: Placebo pretreatment before endometrial preparation for frozen embryo transfer",{"label":21,"type":10,"description":22,"interventionNames":23},"Placebo-Metformin Group","Placebo pretreatment before ovarian stimulation till oocyte retrieval and cryopreservation of all embryos, and followed by metformin pretreatment before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.",[24,14],"Drug: Placebo pretreatment before ovarian stimulation",{"label":26,"type":10,"description":27,"interventionNames":28},"Placebo-Placebo Group","Placebo pretreatment before ovarian stimulation till oocyte retrieval and cryopreservation of all embryos, and followed by placebo pretreatment before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.",[24,19],[30,37,43,49],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Metformin pretreatment before ovarian stimulation","The enrolled patients will be prescribed metformin 850mg twice daily for at least 4 weeks prior to ovarian stimulation till oocyte retrieval.",[9,16],[36],"Metformin before ovarian stimulation",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Placebo pretreatment before ovarian stimulation","The enrolled patients will be prescribed placebo 850mg twice daily for at least 4 weeks prior to ovarian stimulation till oocyte retrieval.",[21,26],[42],"Placebo before ovarian stimulation",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Metformin pretreatment before endometrial preparation for frozen embryo transfer","After oocyte retrieval, the enrolled patients will be prescribed metformin 850mg twice daily for at least 4 weeks before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.",[9,21],[48],"Metformin before endometrial preparation",{"type":31,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Placebo pretreatment before endometrial preparation for frozen embryo transfer","After oocyte retrieval, the enrolled patients will be prescribed placebo 850mg twice daily for at least 4 weeks before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.",[16,26],[54],"Placebo before endometrial preparation",[56],{"name":57,"affiliation":5,"role":58},"Zi-Jiang Chen, Professor","PRINCIPAL_INVESTIGATOR",[60],{"name":57,"role":61,"phone":62,"phoneExt":63,"email":64},"CONTACT","+0086 531 85651190",null,"chenzijiang@vip.163.com",[66],{"facility":5,"status":67,"city":68,"state":69,"zip":63,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"RECRUITING","Jinan","Shandong","China","CN",{"type":73,"coordinates":74},"Point",[75,76],116.99722,36.66833,{"lat":76,"lon":75},[79,80],{"name":57,"role":61,"phone":62,"phoneExt":63,"email":64},{"name":81,"role":61,"phone":82,"phoneExt":63,"email":83},"Daimin Wei, Professor","+0086 531 86561172","sdweidaimin@163.com",{"type":58,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"Chen Zi-Jiang","Academician",[88,91,93,95,97,99,101,103],{"name":89,"class":90},"Ren Ji Hospital of Shanghai Jiao Tong University","UNKNOWN",{"name":92,"class":90},"Women's Hospital of Zhejiang University",{"name":94,"class":6},"Shengjing Hospital",{"name":96,"class":6},"Nanjing Medical University",{"name":98,"class":6},"General Hospital of Ningxia Medical University",{"name":100,"class":6},"West China Second University Hospital",{"name":102,"class":6},"Henan Provincial Maternal and Child Health Care Hospital",{"name":104,"class":90},"Qingdao women's and children's Hospital","100521059","effect-of-metformin-on-healthy-live-birth-in-women-with-prediabetes-100521059",false,"NCT06064669","Effect of Metformin on Healthy Live Birth in Women With Prediabetes","Effect of Metformin on Healthy Live Birth After In-vitro Fertilization in Women With Prediabetes Mellitus: a Multicenter Double-blind Placebo Controlled Randomized Trial","MELT-PreDM","Inclusion Criteria:\n\n1. Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.\n2. Women aged 20-40 years.\n3. Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.\n\nExclusion Criteria:\n\n1. Women who are diagnosed with diabetes according to the ADA criteria11,12, which is meeting one of the following criteria: fasting plasma glucose ≥7.0mmol\u002FL, 2-h plasma glucose during 75-g OGTT ≥11.1mmol\u002FL, HbA1c≥6.5%, or a random plasma glucose≥11.1mmol\u002FL.\n2. Women who are taking medicine that interfere with glucose metabolism, such as metformin, oral anti-diabetic agents (sulfonylureas, glinides, thiazolidinediones, α-glycosidase inhibitors, GLP-1 receptor agonist, etc.), weight loss drugs (i.e.orlistat, etc.), glucocorticoids, and growth hormones within 2 months before enrollment.\n3. Women with un-corrected hyperthyroidism or hypothyroidism.\n4. Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.\n5. Women with a diagnosis of adenomyosis.\n6. Women with untreated hydrosalpinx.\n7. Women who plan to undergo PGT-SR or PGT-M.\n8. Women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.",true,"FEMALE","20 Years","40 Years",{"count":118,"type":119},988,"ESTIMATED","INTERVENTIONAL",[122],"NA","To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.",[125,126,127],"Metformin","Prediabetes","In-Vitro Fertilization","2024-05-27",{"date":130,"type":131},"2024-05-29","ACTUAL",{"date":133,"type":131},"2024-02-22",{"date":135,"type":119},"2027-12-31",{"name":5,"class":6},1]