[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639423":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":131,"collaborators":24,"id":134,"slug":24,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":24,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":157,"whyStopped":24,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"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 gradient centrifugation",{"label":15,"type":10,"description":16,"interventionNames":17},"Second Ejaculate","The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.",[18],"Procedure: Second Ejaculate (collected after 1-3 hours)",[20,25],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Processed using density gradient centrifugation",[9],null,{"type":21,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"Second Ejaculate (collected after 1-3 hours)",[15],[29],{"name":30,"affiliation":31,"role":32},"Vipin Chandra, DGO","Indira IVF Hospital Limited","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Shashank Sanagoudar, MS","CONTACT","91-8050406053","drsanagoudar@gmail.com",{"name":40,"role":36,"phone":24,"phoneExt":24,"email":41},"Sandro Esteves, PhD","s.esteves@androfert.com.br",[43,55,70,78,85,93,101,116,124],{"facility":44,"status":24,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":24},"Recruitment","Patna","Bihar","800014","India",{"type":50,"coordinates":51},"Point",[52,53],85.13563,25.59408,{"lat":53,"lon":52},{"facility":31,"status":24,"city":56,"state":57,"zip":58,"country":48,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Bangalore","Karnataka","560078",{"type":50,"coordinates":60},[61,62],77.59369,12.97194,{"lat":62,"lon":61},[65,68],{"name":66,"role":36,"phone":24,"phoneExt":24,"email":67},"Shyam Gupta, MD","centerhead.bangalore@indiraivf.in",{"name":66,"role":69,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"facility":44,"status":24,"city":71,"state":72,"zip":24,"country":48,"cosmosGeoPoint":73,"geoPoint":77,"contacts":24},"Bhāndup","Maharashtra",{"type":50,"coordinates":74},[75,76],72.93333,19.15,{"lat":76,"lon":75},{"facility":44,"status":24,"city":79,"state":72,"zip":24,"country":48,"cosmosGeoPoint":80,"geoPoint":84,"contacts":24},"Pune",{"type":50,"coordinates":81},[82,83],73.85535,18.51957,{"lat":83,"lon":82},{"facility":44,"status":24,"city":86,"state":87,"zip":24,"country":48,"cosmosGeoPoint":88,"geoPoint":92,"contacts":24},"Delhi","National Capital Territory of Delhi",{"type":50,"coordinates":89},[90,91],77.23149,28.65195,{"lat":91,"lon":90},{"facility":44,"status":24,"city":94,"state":95,"zip":24,"country":48,"cosmosGeoPoint":96,"geoPoint":100,"contacts":24},"Jaipur","Rajasthan",{"type":50,"coordinates":97},[98,99],75.78781,26.91962,{"lat":99,"lon":98},{"facility":102,"status":24,"city":103,"state":95,"zip":104,"country":48,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"LAB","Udaipur","313001",{"type":50,"coordinates":106},[107,108],73.71346,24.58584,{"lat":108,"lon":107},[111,114],{"name":112,"role":36,"phone":113,"phoneExt":24,"email":38},"Shashank Sannagoudar, MS","8050406053",{"name":30,"role":36,"phone":24,"phoneExt":24,"email":115},"drvipinchandra@indiraivf.in",{"facility":44,"status":24,"city":117,"state":118,"zip":24,"country":48,"cosmosGeoPoint":119,"geoPoint":123,"contacts":24},"Allahābād","Uttar Pradesh",{"type":50,"coordinates":120},[121,122],78.37997,29.22096,{"lat":122,"lon":121},{"facility":44,"status":24,"city":125,"state":118,"zip":24,"country":48,"cosmosGeoPoint":126,"geoPoint":130,"contacts":24},"Lucknow",{"type":50,"coordinates":127},[128,129],80.92313,26.83928,{"lat":129,"lon":128},{"type":32,"investigatorFullName":132,"investigatorTitle":133,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Dr Vipin Chandra","Chief Clinical and Lab Operations","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":144,"type":145},830,"ESTIMATED","INTERVENTIONAL",[148],"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.",[151],"Male",[153,15,154,155,156],"pregnancy rate","Abstinence","Microfluidic","CA0","NOT_YET_RECRUITING","2026-05-30",{"date":160,"type":161},"2026-06-04","ACTUAL",{"date":163,"type":145},"2026-08-05",{"date":165,"type":145},"2028-03-25",{"name":5,"class":6},9]