[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385403":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":34,"locations":40,"responsibleParty":64,"collaborators":66,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":24,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ROSI only","EXPERIMENTAL","Option 1: injecting extracted round spermatids (less mature form of haploid germ cells than elongated spermatid or spermatozoon) from male partner into the harvested egg of a female partner",[13],"Other: Round Spermatid Injection (ROSI)",{"label":15,"type":10,"description":16,"interventionNames":17},"Half ROSI-half Sperm Donor Fertilization","Option 2: Harvested eggs from the female partner will be separated in two groups, with one group being fertilized with round spermatids and the other group fertilized with donor sperm",[18],"Other: Half ROSI-half Sperm Donor Fertilization",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Round Spermatid Injection (ROSI)","In Vitro Fertilization using Round Spermatid Injection (ROSI)",[9],null,{"type":6,"name":15,"description":15,"armGroupLabels":26,"otherNames":24},[15],[28,32],{"name":29,"affiliation":30,"role":31},"Hooman Sadri, MD, PhD","Wake Forest Institute for Regenerative Medicine (WFIRM)","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":5,"role":33},"STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Karla M Oliver","CONTACT","336-713-3123","kaoliver@wakehealth.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Carolinas Fertility Institute (CFI)","RECRUITING","Winston-Salem","North Carolina","27103","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-80.24422,36.09986,{"lat":53,"lon":52},[56,58,59,62],{"name":57,"role":31,"phone":24,"phoneExt":24,"email":24},"Tamer Yalcinkaya, MD",{"name":29,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":60,"role":61,"phone":24,"phoneExt":24,"email":24},"Banafsheh Nikmehr, PhD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":24,"phoneExt":24,"email":24},"Anuradha Devineni, MD, MS",{"type":65,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[67,69,70],{"name":42,"class":68},"UNKNOWN",{"name":30,"class":68},{"name":71,"class":68},"Wake Forest Department of Urology","100385403","experimental-round-spermatid-injection-rosi-to-treat-infertile-couples-100385403",false,"NCT04298255","Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples","ROSI","Inclusion Criteria:\n\n* Males with no elongated spermatids or spermatozoa present but with round spermatids present on TESE (Testicular Sperm Extraction)\n* Male diagnosed with non-obstructive Azoospermia\n* Male partner ≥18\n* Female partner greater than 18 years of age and less than 38 years of age or Anti Mullerian Hormone (AMH) greater than 2 ng\u002Fml.\n\nExclusion Criteria:\n\n* Males with obstructive azoospermia\n* Males with presence an adequate number of elongated spermatids or spermatozoa","MALE","18 Years",{"count":82,"type":83},50,"ESTIMATED","INTERVENTIONAL",[86],"NA","The purpose of this research study is to evaluate if special types of cells called round spermatids can be gathered from men with non-obstructive azoospermia and used (in absence of elongated spermatids and spermatozoa) to reliably and effectively create pregnancy with a procedure called Round Spermatid Injection (ROSI). This process is similar to In Vitro Fertilization, or 'IVF'. In addition, this study wants to test the safety of ROSI and see what effects (good and bad) it has on embryo created from this method.",[89],"Infertility, Male",[91,92],"IVF","Fertility","2025-09-15",{"date":95,"type":96},"2025-09-16","ACTUAL",{"date":98,"type":96},"2020-08-24",{"date":100,"type":83},"2026-07",{"name":5,"class":6},1]