[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564483":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":58,"collaborators":31,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":31,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":83,"overallStatus":46,"whyStopped":31,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Reproductive Medicine Associates of New Jersey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device","EXPERIMENTAL","Half of the mature oocytes will be randomly allocated to receive sperm prepared by the microfluidic (Zymot) sperm preparation device. This sperm will be used by the embryologist for the ICSI procedure.",[13],"Device: Microfluidic sperm separation device",{"label":15,"type":6,"description":16,"interventionNames":17},"Oocytes inseminated by sperm prepared via density grade centrifugation","The other half of the mature oocytes will be allocated to receive sperm prepared by DGC. This sperm will be used by the embryologist for the ICSI procedure.",[18],"Other: Density grade centrifugation",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Microfluidic sperm separation device","An aliquot of 850ul will be used for the Zymot sperm selection device. The sperm processing via Zymot will be per manufacturer's guidelines",[9],[26],"Zymot",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Density grade centrifugation","5ul of the ejaculated sample will be assessed for DGC via Makler assessment. If the sample for DGC is adequate per lab standard operating procedures, then routine DGC sperm preparation and embryologist sperm selection for the ICSI procedure will occur.",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Kassie Bollig, MD, MSCE","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Caroline Clinical Research Nurse, BSN, RN","CONTACT","973-656-2841","clinicalresearchteam@ivirma.com",{"name":43,"role":39,"phone":40,"phoneExt":31,"email":41},"Christine Director of Research Operations, MS, BSN, RN",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":31},"RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-74.54932,40.70621,{"lat":56,"lon":55},{"type":59,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100564483","the-epic-study-exploring-paternal-age-and-the-influence-on-blastocyst-culture-100564483",false,"NCT06629766","The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture","EPIC","Inclusion Criteria:\n\n* Undergoing first IVF cycle\n* Electing single embryo transfer\n* Electing PGT-A of their embryos\n* Female partners age \\\u003C42 years old at start of VOR cycle, but \\>18 years old.\n* AMH ≥ 1.2 ng\u002FmL\n* AFC ≥ 8\n* FSH ≤ 12IU\u002FL\n* At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize\n* Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure\n\nExclusion Criteria:\n\n* Contraindication to IVF\n* Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)\n* Male partner with azoospermia or oligozoospermia (\\\u003C500,000 total motile spermatozoa on the most recent semen analysis within one year of enrollment)\n* Planned for previously cryopreserved sperm to be used for ICSI\n* Donor sperm\n* Male partner with Y-chromosome microdeletion\n* Male partner with any Karyotype other than 46,XY\n* Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures\n* Uncorrected hydrosalpinges that communicate with the endometrial cavity\n* Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \\\u003C6mm,), or persistent endometrial fluid\n* Donor oocyte or embryo cycles\n* Gestational carriers","FEMALE","18 Years","41 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.",[78,79,80,81,82],"Infertility (IVF Patients)","Oocyte Competence","Sperm DNA Fragmentation","Paternal Age","Sperm Selection",[84,85,86,87,88,26],"microfluidic","density grade centrifugation","sperm selection","paternal age","sperm DNA fragmentation","2026-06-01",{"date":91,"type":92},"2026-06-03","ACTUAL",{"date":94,"type":92},"2025-04-09",{"date":96,"type":72},"2028-12",{"name":5,"class":6},1]