[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629736":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":64,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":25,"overallStatus":85,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Fecundis Lab SL","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Sperm Preparation","ACTIVE_COMPARATOR","Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.",[13],"Device: Standard Sperm Preparation",{"label":15,"type":16,"description":17,"interventionNames":18},"HyperSperm","EXPERIMENTAL","Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.",[19],"Device: HyperSperm",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Standard sperm preparation",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Multi-step sperm preparation",[15],[30],{"name":31,"affiliation":5,"role":32},"Mariano G Buffone, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":37,"email":38},"CONTACT","+54114783 2869","+1314","buffone@fecundis.com",[40,58],{"facility":41,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"IFER","Buenos Aires","Buenos Aires F.D.","1115","Argentina","AR",{"type":48,"coordinates":49},"Point",[50,51],-58.37723,-34.61315,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":25,"email":57},"Fabian Lorenzo, MD","+54 9 11 6707-8521","fabian.lorenzo@hotmail.com",{"facility":59,"status":25,"city":42,"state":43,"zip":60,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":63,"contacts":25},"Pregna","1425",{"type":48,"coordinates":62},[50,51],{"lat":51,"lon":50},{"type":65,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100629736","safety-evaluation-of-the-hypersperm-sperm-preparation-procedure-for-in-vitro-fertilization-100629736",false,"NCT07478549","Safety Evaluation of the HyperSperm Sperm Preparation Procedure for In Vitro Fertilization","Prospective, Multicenter, Randomized Clinical Trial Evaluating the Safety of the HyperSperm Sperm Preparation Procedure.","Inclusion Criteria:\n\nGeneral\n\n* Couples undergoing in vitro fertilization (IVF) treatment.\n* Planned use of fresh sperm samples obtained by masturbation.\n\nFemale\n\n* Age between 20 and 42 years.\n* Antral follicle count ≥ 4.\n* Eligible for ovarian stimulation and embryo transfer.\n\nMale\n\n* Age between 20 and 45 years.\n* Fresh semen sample (not cryopreserved).\n* Pre-processing sperm concentration ≥ 5 × 10⁶ sperm\u002FmL.\n\nExclusion Criteria:\n\nGeneral\n\n* Active sexually transmitted infection (STI).\n* Use of donor sperm.\n* Medical conditions contraindicating pregnancy or the IVF procedure.\n\nFemale\n\n* Uterine anomalies associated with distortion of the uterine cavity.\n* Absence of one ovary or functional disorders preventing ovulation.\n* Diabetes mellitus or other metabolic disorders.\n* Recurrent pregnancy loss, defined as more than two clinical pregnancies without live birth.\n\nMale\n\n\\- Any medical condition affecting semen quality that, in the investigator's opinion, may interfere with study participation.","ALL","20 Years","45 Years",{"count":77,"type":78},202,"ESTIMATED","INTERVENTIONAL",[81],"NA","Prospective, multicenter, randomized clinical study evaluating the safety of a novel sperm preparation method for in vitro fertilization (IVF), compared to standard sperm preparation procedures.",[84],"Infertility","NOT_YET_RECRUITING","2026-06-23",{"date":88,"type":89},"2026-06-26","ACTUAL",{"date":91,"type":78},"2026-12",{"date":93,"type":78},"2028-05",{"name":5,"class":6},2]