[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovulation-induction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovulation-induction":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100587930",false,"NCT06934785","LE + CC vs. LE for Ovulation Induction","The Combination of Letrozole (LE) and Clomiphene Citrate (CC) or LE Alone for Ovulation Induction in Women With WHO Group II\u002FIV Ovulatory Disorders: A Randomized Controlled Trial","COLA","Inclusion Criteria:\n\n* Women 18-40 years of age\n* Having WHO II\u002FIV ovulatory disorders (length of cycle \\\u003C 21 or \\> 35 days or having \\\u003C 8 cycles per year)\n* Progressive motility (PR) ≥ 32%, sperm concentration ≥ 5 million\u002Fml, total progressive motility sperm count \\> 5 million (World Health Organization, 2021)\n* Written informed consent.\n* Not participating in other studies.\n\nExclusion Criteria:\n\n* Untreated thyroid disease; Thyroid disease is suspected if patients have one of these (Bednarczuk et al., 2021); TSH ≥4 mIU\u002FL or TSH ≥2.5mIU\u002FL and TPOAb (+) or TSH \\\u003C0.1mIU\u002FL\n* Untreated hyper-prolactinemia; Hyperprolactinemia is suspected if patients have prolactinemia concentration \\>50 ng\u002FmL (The sample is collected after an overnight fast, at least 2 hours after waking up, ensuring that venipuncture does not cause excessive stress.)\n* Allergy or having contraindications to LE or CC;\n* Unilateral or Bilateral fallopian tube blockage (HSG, HyFoSy or surgery confirmation)\n* Untreated endometrial abnormalities include endometrial hyperplasia, intrauterine adhesions, endometrial polyp, or chronic endometritis.\n* Uterine abnormalities include leiomyomas L0, L1, or L2; severe adenomyosis; congenital uterine abnormalities, include didelphus, arcuate, unicornuate, bicornuate, septate.","FEMALE","18 Years","40 Years",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized controlled trial (RCT) aims to evaluate whether, in infertile women with WHO II\u002FIV ovulatory disorders, a combination of letrozole (LE) and clomiphene citrate (CC) compared to LE alone, result in higher live birth rates.\n\nThe study is designed as an open-label, multicenter RCT across six fertility clinics in Vietnam. Participants will be randomized into two groups: (1) LE + CC , (2) LE alone. The primary outcome measure is the live birth rate after one treatment cycle. Based on prior data, the live birth rate for IUI in letrozole cycles is estimated at 12%. To detect a 10% increase in live birth rates with CC, 436 couples are needed (α = 0.05, power = 80%). Additionally, the live birth rate after IUI with LE-induced ovulation is approximately 18.7% (Diamond et al., 2015). To detect a 10% increase with CC, 560 couples are required (α = 0.05, power = 80%). Considering a 5% loss to follow-up and protocol deviations, the study plans to recruit 600 participants (150 per arm).",[27,28,29,30],"Letrozole","Clomiphene Citrate","Ovulation Disorder","Ovulation Induction","RECRUITING","2025-09-04",{"date":34,"type":35},"2025-09-11","ACTUAL",{"date":37,"type":35},"2025-04-28",{"date":39,"type":21},"2027-06-30",{"name":41,"class":42},"Mỹ Đức Hospital","OTHER",""]