[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100519258","best-treatment-for-women-with-both-polycystic-ovary-syndrome-pcos-and-subclinical-hypothyroidism-100519258",false,"NCT06041204","Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism","Letrozole Alone vs. Letrozole Plus Levothyroxine for Ovulation Induction in Infertile Women With Both (Polycystic Ovary Syndrome) PCOS and Sub-clinical Hypothyroidism.","Inclusion Criteria:\n\nAge between 20-40 years\n\nBMI between 18-35 kg\u002Fm2\n\nMeet diagnostic criteria for PCOS based on the Rotterdam consensus criteria and ESHRE\u002FASRM modifications (2018):\n\nOligo- and\u002For anovulation Clinical and\u002For biochemical signs of hyperandrogenism Polycystic ovaries on ultrasound\n\nSubclinical hypothyroidism defined as TSH level between 5-10 mIU\u002FL with normal free T4\n\nInfertility duration ≥ 1 year\n\nIntact ovaries and uterus, confirmed by physical exam and imaging\n\nNormal semen analysis in male partner\n\nNo tubal or peritoneal factor contributing to infertility\n\nEffective contraception if not attempting conception\n\nWilling and able to provide informed consent\n\nExclusion Criteria:\n\nKnown thyroid disease or on thyroid medications\n\nAbnormal thyroid function tests other than subclinical hypothyroidism\n\nHyperprolactinemia\n\nPresence of other causes of infertility such as:\n\nModerate to severe male factor infertility Bilateral tubal occlusion or peritoneal factors Stage III-IV endometriosis Ovarian failure or insufficiency (high FSH or low AMH)\n\nPrevious diagnosis of any type of congenital adrenal hyperplasia\n\nUncontrolled diabetes (HbA1C \\>8%)\n\nHistory of deep vein thrombosis or thromboembolic events\n\nAny contraindication to letrozole or levothyroxine\n\nPrevious use of letrozole or levothyroxine in past 6 months\n\nCurrent or suspected pregnancy\n\nBreastfeeding\n\nInability to comply with treatment and follow-up procedures","FEMALE","20 Years","40 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this randomized controlled trial is to compare letrozole alone versus letrozole plus levothyroxine for ovulation induction in infertile women with both PCOS and subclinical hypothyroidism. The main questions it aims to answer are:\n\nIs letrozole plus levothyroxine superior to letrozole alone in achieving ovulation in these patients? Does combining levothyroxine with letrozole lead to higher pregnancy and live birth rates compared to letrozole alone?\n\nParticipants will be randomized into two groups:\n\nGroup 1 will receive letrozole only, starting at 2.5 mg daily from day 3 to 7 of the menstrual cycle. The dose will be increased up to 7.5 mg if no ovulation occurs, for a maximum treatment period of 6 months or until pregnancy is achieved.\n\nGroup 2 will receive letrozole at the same doses as group 1 plus 25 mcg levothyroxine daily.",[27,28,29],"PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries","Subclinical Hypothyroidism","Female Infertility",[31,32,33,34],"Letrozole","Levothyroxine","PCOS","Subclinical hypothyroidism","RECRUITING","2025-08-30",{"date":38,"type":39},"2025-09-03","ACTUAL",{"date":41,"type":39},"2021-05-06",{"date":43,"type":21},"2026-06-28",{"name":45,"class":46},"Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy","OTHER",""]