[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634509":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":52,"studyPopulation":52,"armGroups":59,"interventions":70,"overallOfficials":52,"centralContacts":77,"locations":83,"responsibleParty":179,"collaborators":52,"id":183,"slug":52,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":190,"sex":191,"minAge":52,"maxAge":52,"enrollmentInfo":192,"targetDuration":52,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":206,"whyStopped":52,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Indira IVF Hospital Pvt Ltd","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Success or Sperm Availability","Sperm Availability for ICSI was defined as the presence of viable sperm suitable for intracytoplasmic sperm injection (ICSI) at any time from randomization through Week 16. Sperm could be obtained either through ejaculate or via microsurgical testicular sperm extraction (micro-TESE). Assessment of sperm availability was performed by a centralized adjudication committee, which was blinded to treatment allocation to ensure objective and unbiased evaluation.","from randomization through Week 16 via ejaculate or micro-TESE",[14,18,22,26,30,34,37,40,44,48],{"measure":15,"description":16,"timeFrame":17},"Micro-TESE Sperm Retrieval Rate (SSR)","Whether sperm are retrieved during micro-TESE","The Micro-TESE Sperm Retrieval Rate (SSR) was assessed during the period from randomization through Week 16. The outcome was determined based on the availability of at least one viable sperm retrieved via microsurgical testicular sperm extraction (micro-",{"measure":19,"description":20,"timeFrame":21},"Need for Micro-TESE Surgery","Whether the participant requires micro-TESE","Up to Week 16",{"measure":23,"description":24,"timeFrame":25},"Safety \u002F Harms","All adverse events (AE\u002FSAE) related to treatment or procedure","Week 16",{"measure":27,"description":28,"timeFrame":29},"ICSI Fertilization Rate","% of injected oocytes that form normal 2PN embryos","Within the ICSI cycle ≈ Day 1-3 after ICSI",{"measure":31,"description":32,"timeFrame":33},"Blastulation Rate","% of embryos reaching blastocyst stage","Day 5-7 after fertilization",{"measure":35,"description":36,"timeFrame":33},"Blastocyst Quality","Grading of blastocysts based on standard morphology criteria",{"measure":38,"description":39,"timeFrame":33},"Top-Quality Blastocyst Rate","% of \"top-1 quality\" blastocysts formed",{"measure":41,"description":42,"timeFrame":43},"Clinical Pregnancy Rate","Presence of gestational sac with cardiac activity on ultrasound","≈ 6-8 weeks after embryo transfer",{"measure":45,"description":46,"timeFrame":47},"Miscarriage Rate","Pregnancy loss before 20 weeks","From pregnancy confirmation to 20 weeks gestation",{"measure":49,"description":50,"timeFrame":51},"Live Birth","Delivery of a live infant","Up to delivery (~9 months after embryo transfer)",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":52,"primaryPurpose":56,"observationalModel":52,"timePerspective":52,"maskingInfo":57},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":58,"maskingDescription":52,"whoMasked":52},"NONE",[60,65],{"label":61,"type":62,"description":52,"interventionNames":63},"hCG + FSH therapy","EXPERIMENTAL",[64],"Other: hCG + FSH therapy",{"label":66,"type":67,"description":52,"interventionNames":68},"Standard of Care","ACTIVE_COMPARATOR",[69],"Other: No intervention",[71,74],{"type":6,"name":72,"description":66,"armGroupLabels":73,"otherNames":52},"No intervention",[66],{"type":6,"name":61,"description":75,"armGroupLabels":76,"otherNames":52},"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",[61],[78],{"name":79,"role":80,"phone":81,"phoneExt":52,"email":82},"Vipin Chandra, DGO","CONTACT","9567971239","drvipinchandra@indiraivf.in",[84,101,115,127,137,145,158,169],{"facility":85,"status":52,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Recruitment","Patna","Bihar","800014","India","IN",{"type":92,"coordinates":93},"Point",[94,95],85.13563,25.59408,{"lat":95,"lon":94},[98],{"name":99,"role":80,"phone":100,"phoneExt":52,"email":52},"Dayaniddhi Kumar, Ph D","9011803606",{"facility":85,"status":52,"city":102,"state":103,"zip":104,"country":89,"countryCode":90,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Bangalore","Karnataka","560041",{"type":92,"coordinates":106},[107,108],77.59369,12.97194,{"lat":108,"lon":107},[111],{"name":112,"role":80,"phone":113,"phoneExt":52,"email":114},"Shyam Gupta, MD","9899984791","centerhead.bangalore@indiraivf.in",{"facility":85,"status":52,"city":116,"state":117,"zip":52,"country":89,"countryCode":90,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Bhāndup","Maharashtra",{"type":92,"coordinates":119},[120,121],72.93333,19.15,{"lat":121,"lon":120},[124],{"name":125,"role":80,"phone":126,"phoneExt":52,"email":52},"Rinoy Shreedharan, MD","+917874071247",{"facility":85,"status":52,"city":128,"state":117,"zip":52,"country":89,"countryCode":90,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Pune",{"type":92,"coordinates":130},[131,132],73.85535,18.51957,{"lat":132,"lon":131},[135],{"name":136,"role":80,"phone":52,"phoneExt":52,"email":52},"Amol Lunkad, MD",{"facility":85,"status":52,"city":138,"state":139,"zip":52,"country":89,"countryCode":90,"cosmosGeoPoint":140,"geoPoint":144,"contacts":52},"Delhi","National Capital Territory of Delhi",{"type":92,"coordinates":141},[142,143],77.23149,28.65195,{"lat":143,"lon":142},{"facility":85,"status":52,"city":146,"state":147,"zip":52,"country":89,"countryCode":90,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Jaipur","Rajasthan",{"type":92,"coordinates":149},[150,151],75.78781,26.91962,{"lat":151,"lon":150},[154],{"name":155,"role":80,"phone":156,"phoneExt":52,"email":157},"Tanu Batra, MD","09567971239","ifa@indiraivf.in",{"facility":85,"status":52,"city":159,"state":160,"zip":52,"country":89,"countryCode":90,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Allahābād","Uttar Pradesh",{"type":92,"coordinates":162},[163,164],78.37997,29.22096,{"lat":164,"lon":163},[167],{"name":168,"role":80,"phone":52,"phoneExt":52,"email":52},"Anjali Gahlan, MS",{"facility":85,"status":52,"city":170,"state":160,"zip":52,"country":89,"countryCode":90,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Lucknow",{"type":92,"coordinates":172},[173,174],80.92313,26.83928,{"lat":174,"lon":173},[177],{"name":178,"role":80,"phone":52,"phoneExt":52,"email":52},"Pawan Yadav, MD",{"type":180,"investigatorFullName":181,"investigatorTitle":182,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"PRINCIPAL_INVESTIGATOR","Dr Vipin Chandra","Chief Clinical Lab Operations","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":193,"type":194},860,"ESTIMATED","INTERVENTIONAL",[197],"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",[200],"APHRODITE Group",[202,203,204,205],"Non-obstructive azoospermia (NOA)","Idiopathic NOA","Male infertility","Hypogonadism","NOT_YET_RECRUITING","2026-04-14",{"date":209,"type":210},"2026-04-20","ACTUAL",{"date":212,"type":194},"2026-07-17",{"date":214,"type":194},"2027-07-17",{"name":5,"class":6},8]