[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639423":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":132,"collaborators":24,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":24,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":159,"whyStopped":24,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Indira IVF Hospital Pvt Ltd","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"First Ejaculate","EXPERIMENTAL","Processed using a centrifugation-free sperm sorting device",[13],"Procedure: Processed using density 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Pradesh",{"type":51,"coordinates":121},[122,123],78.37997,29.22096,{"lat":123,"lon":122},{"facility":44,"status":24,"city":126,"state":119,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":127,"geoPoint":131,"contacts":24},"Lucknow",{"type":51,"coordinates":128},[129,130],80.92313,26.83928,{"lat":130,"lon":129},{"type":32,"investigatorFullName":133,"investigatorTitle":134,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Dr Vipin Chandra","Chief Clinical and Lab Operations","100639423","randomized-non-inferiority-within-patient-trial-of-density-gradient-processing-of-sequential-ejaculates-versus-centrifugation-free-sperm-separation-device-for-icsi-in-men-with-elevated-sperm-dna-fragmentation-100639423",false,"NCT07626359","Randomized Non-inferiority Within-Patient Trial of Density Gradient Processing of Sequential Ejaculates Versus Centrifugation-free Sperm Separation Device for ICSI in Men With Elevated Sperm DNA Fragmentation.","SE","Inclusion Criteria:\n\n* • Elevated SDF defined as DFI \\>20 %measured by the sperm chromatin dispersion (SCD) test performed in a participating center's andrology laboratory, using a harmonized protocol under standardized conditions after 2-3 days of ejaculatory abstinence, and within 90 days (≤3 months) prior to enrollment.\n\n  * Male partners 21-45 years;\n  * Female partners 21-35 years.\n  * Undergoing IVF\u002FICSI.\n  * No known genetic or chromosomal abnormalities.\n  * Minimum 4 MII oocyte patients shall be included\n\nExclusion Criteria:\n\n* Azoospermia or severe oligoasthenozoospermia (\\\u003C1 million motile sperm\u002FmL).\n* Significant systemic disease (e.g., uncontrolled diabetes, malignancy).\n* History of a prior ICSI cycle with no embryo development.\n* Relevant female factors: untreated adnexal pathology ,a history of a thin endometrium (\\\u003C7 mm) following endometrium preparation for embryo transfer","ALL","21 Years","45 Years",{"count":146,"type":147},830,"ESTIMATED","INTERVENTIONAL",[150],"NA","Elevated SDF can adversely impact fertilization, embryo development, and pregnancy outcomes in IVF-ICSI cycles. Two pragmatic strategies aim to reduce SDF on the day of ICSI: (i) obtaining a second ejaculate shortly after the first to reduce oxidative damage and transit time; and (ii) selecting sperm via centrifugation-free sperm separation device, which enriches for motile sperm with intact DNA. There are limited direct comparisons between these strategies; this study addresses that gap.",[153],"Male",[155,15,156,157,158],"pregnancy rate","Abstinence","Microfluidic","CA0","NOT_YET_RECRUITING","2026-05-30",{"date":162,"type":163},"2026-06-04","ACTUAL",{"date":165,"type":147},"2026-08-05",{"date":167,"type":147},"2028-03-25",{"name":5,"class":6},9]