[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492521":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":23,"studyPopulation":13,"armGroups":24,"interventions":36,"overallOfficials":45,"centralContacts":49,"locations":58,"responsibleParty":79,"collaborators":13,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":13,"enrollmentInfo":91,"targetDuration":13,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":105,"overallStatus":61,"whyStopped":13,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative clinical pregnancy rate","The clinical pregnancy rate by treatment group over the course of IUI treatment","3 treatment cycles, an average of 5 months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"DOUBLE",[21,22],"PARTICIPANT","CARE_PROVIDER","Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.",[25,31],{"label":26,"type":27,"description":28,"interventionNames":29},"Density gradient centrifugation","ACTIVE_COMPARATOR","Patients will undergo sperm preparation by density gradient centrifugation",[30],"Other: Density gradient centrifugation",{"label":32,"type":27,"description":33,"interventionNames":34},"Zymot sperm separation device","Patients will undergo sperm preparation by the Zymot sperm separation device",[35],"Device: Zymot Multi sperm separation device",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"DEVICE","Zymot Multi sperm separation device","Sperm preparation with Zymot Multi sperm preparation device",[32],{"type":6,"name":26,"description":43,"armGroupLabels":44,"otherNames":13},"Sperm preparation with density gradient centrifugation",[26],[46],{"name":47,"affiliation":5,"role":48},"Mitchell Rosen, MD","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":13,"email":54},"Alisha T Tolani, MD","CONTACT","6282867307","alisha.tolani@ucsf.edu",{"name":56,"role":52,"phone":13,"phoneExt":13,"email":57},"Elena Hoskin","elena.hoskin@ucsf.edu",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"UCSF Center for Reproductive Health","RECRUITING","San Francisco","California","94158","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-122.41942,37.77493,{"lat":71,"lon":70},[74,76,77,78],{"name":51,"role":52,"phone":75,"phoneExt":13,"email":54},"628-286-7307",{"name":56,"role":52,"phone":13,"phoneExt":13,"email":57},{"name":51,"role":48,"phone":13,"phoneExt":13,"email":13},{"name":47,"role":48,"phone":13,"phoneExt":13,"email":13},{"type":80,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100492521","sperm-preparation-prior-to-intrauterine-insemination-study-100492521",false,"NCT05693220","Sperm Preparation Prior to Intrauterine Insemination Study","The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)","PIoUS","Inclusion Criteria:\n\n* Patients undergoing intrauterine insemination\n* Patient assigned female at birth with age \\\u003C41\n\nExclusion Criteria:\n\n* Any significant disease or psychiatric disorder that would interfere with the consenting process\n* Prior intrauterine insemination\n* Use of frozen donor sperm\n* Non-English speaker","ALL","18 Years",{"count":92,"type":93},270,"ESTIMATED","INTERVENTIONAL",[96],"NA","This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.",[99,100,101,102,103,104],"Infertility","Infertility Secondary","Infertility Unexplained","Anovulation","Fertility Disorders","Reproductive Issues",[106,107,108,99],"Intrauterine Insemination","Insemination","Fertility","2026-09-11",{"date":111,"type":112},"2026-09-15","ACTUAL",{"date":114,"type":112},"2023-02-05",{"date":116,"type":93},"2027-12-31",{"name":5,"class":6},1]