[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634509":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":26,"locations":32,"responsibleParty":128,"collaborators":11,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":140,"sex":141,"minAge":11,"maxAge":11,"enrollmentInfo":142,"targetDuration":11,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":156,"whyStopped":11,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Indira IVF Hospital Pvt Ltd","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"hCG + FSH therapy","EXPERIMENTAL",null,[13],"Other: hCG + FSH therapy",{"label":15,"type":16,"description":11,"interventionNames":17},"Standard of Care","ACTIVE_COMPARATOR",[18],"Other: No intervention",[20,23],{"type":6,"name":21,"description":15,"armGroupLabels":22,"otherNames":11},"No intervention",[15],{"type":6,"name":9,"description":24,"armGroupLabels":25,"otherNames":11},"hCG + FSH therapy with monthly hormone-driven titration (hCG initial \\~83 µg SC twice weekly; no preset min\u002Fmax; target TT \\>350-900 ng\u002FdL) + FSH 150 IU SC twice weekly (increase to 150 IU SC three times weekly if 'FSH reset' \\\u003C1.5 IU\u002FL); allow anastrozole 1 mg PO daily \u002Fletrozole 2.5 mg half tablet alternate day if T\u002FE \\\u003C10",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Vipin Chandra, DGO","CONTACT","9567971239","drvipinchandra@indiraivf.in",[33,50,64,76,86,94,107,118],{"facility":34,"status":11,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Recruitment","Patna","Bihar","800014","India","IN",{"type":41,"coordinates":42},"Point",[43,44],85.13563,25.59408,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":49,"phoneExt":11,"email":11},"Dayaniddhi Kumar, Ph D","9011803606",{"facility":34,"status":11,"city":51,"state":52,"zip":53,"country":38,"countryCode":39,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Bangalore","Karnataka","560041",{"type":41,"coordinates":55},[56,57],77.59369,12.97194,{"lat":57,"lon":56},[60],{"name":61,"role":29,"phone":62,"phoneExt":11,"email":63},"Shyam Gupta, MD","9899984791","centerhead.bangalore@indiraivf.in",{"facility":34,"status":11,"city":65,"state":66,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Bhāndup","Maharashtra",{"type":41,"coordinates":68},[69,70],72.93333,19.15,{"lat":70,"lon":69},[73],{"name":74,"role":29,"phone":75,"phoneExt":11,"email":11},"Rinoy Shreedharan, MD","+917874071247",{"facility":34,"status":11,"city":77,"state":66,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Pune",{"type":41,"coordinates":79},[80,81],73.85535,18.51957,{"lat":81,"lon":80},[84],{"name":85,"role":29,"phone":11,"phoneExt":11,"email":11},"Amol Lunkad, MD",{"facility":34,"status":11,"city":87,"state":88,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":89,"geoPoint":93,"contacts":11},"Delhi","National Capital Territory of Delhi",{"type":41,"coordinates":90},[91,92],77.23149,28.65195,{"lat":92,"lon":91},{"facility":34,"status":11,"city":95,"state":96,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Jaipur","Rajasthan",{"type":41,"coordinates":98},[99,100],75.78781,26.91962,{"lat":100,"lon":99},[103],{"name":104,"role":29,"phone":105,"phoneExt":11,"email":106},"Tanu Batra, MD","09567971239","ifa@indiraivf.in",{"facility":34,"status":11,"city":108,"state":109,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Allahābād","Uttar Pradesh",{"type":41,"coordinates":111},[112,113],78.37997,29.22096,{"lat":113,"lon":112},[116],{"name":117,"role":29,"phone":11,"phoneExt":11,"email":11},"Anjali Gahlan, MS",{"facility":34,"status":11,"city":119,"state":109,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Lucknow",{"type":41,"coordinates":121},[122,123],80.92313,26.83928,{"lat":123,"lon":122},[126],{"name":127,"role":29,"phone":11,"phoneExt":11,"email":11},"Pawan Yadav, MD",{"type":129,"investigatorFullName":130,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Dr Vipin Chandra","Chief Clinical Lab Operations","100634509","gonadotropin-therapy-in-idiopathic-hypogonadal-non-obstructive-100634509",false,"NCT07540611","Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive","\"Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive Azoospermia (APHRODITE Groups 3-4): A Multicenter Randomized Controlled Trial\"","GTIHNO","Inclusion Criteria:\n\n\\- Idiopathic NOA; hypogonadal (TT \\\u003C350 ng\u002FdL on two fasting morning tests); FSH ≥7.6 IU\u002FL (APHRODITE Group 3: 7.6-12.0 IU\u002FL; Group 4: \\>12.0 IU\u002FL).\n\nExclusion Criteria:\n\ncryptorchidism, chemo\u002Fradiation, genetic NOA (e.g., AZFa\u002Fcomplete AZFb), testicular trauma\u002Ftorsion, post-orchitis. prior micro-TESE within 12 months; recent gonadotropin therapy (\\\u003C6 months); uncontrolled endocrine disease; active malignancy; severe liver disease; polycythemia (Hct\\>50%); inability to comply. Varicocele\\>= Grade 3",true,"MALE",{"count":143,"type":144},860,"ESTIMATED","INTERVENTIONAL",[147],"NA","The goal of this clinical trial is to determine whether short-term gonadotropin therapy (hCG + FSH) can increase sperm availability for ICSI in men with idiopathic non-obstructive azoospermia (NOA) and hypogonadism. The main questions it aims to answer are:\n\nDoes hormonal optimization improve the likelihood of obtaining usable sperm (via ejaculate or micro-TESE) by Week 16? Does hormonal therapy reduce the need for micro-TESE or improve downstream embryological and clinical outcomes?\n\nBecause there is a comparison group, researchers will compare hCG + FSH hormonal therapy with standard-of-care (no gonadotropins) to see if hormonal optimization increases sperm retrieval success and decreases surgical reliance.\n\nParticipants will:\n\nUndergo baseline hormonal and semen testing Be randomized to either hormonal therapy or standard-of-care If in the hormonal arm: receive hCG and FSH with monthly dose titration and aromatase inhibitors if indicated Provide semen samples at Weeks 12 and 16 Undergo micro-TESE if no ejaculated sperm are found (timing per protocol) Complete safety assessments and follow-up through Week 16",[150],"APHRODITE Group",[152,153,154,155],"Non-obstructive azoospermia (NOA)","Idiopathic NOA","Male infertility","Hypogonadism","NOT_YET_RECRUITING","2026-04-14",{"date":159,"type":160},"2026-04-20","ACTUAL",{"date":162,"type":144},"2026-07-17",{"date":164,"type":144},"2027-07-17",{"name":5,"class":6},8]