[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545132":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":56,"collaborators":23,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":23,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":23,"overallStatus":38,"whyStopped":23,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Reproductive Medicine Associates of New Jersey","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Cleavage Stage Assisted Hatching (AH)","Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser.",[12],"Other: Laser Assisted Hatching",{"label":14,"type":15,"description":16,"interventionNames":17},"Blastocyst Stage Assisted Hatching (AH)","EXPERIMENTAL","Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser.",[12],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Laser Assisted Hatching","Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.",[14,9],null,[25],{"name":26,"affiliation":5,"role":27},"Jason Fransiak, MD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Christine V Whitehead, MS, BSN, RN","CONTACT","19736562841","clinicalresearchteam@ivirma.com",{"name":35,"role":31,"phone":32,"phoneExt":23,"email":33},"Caroline Zuckerman, BS, RN",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Marlton","New Jersey","08053","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-74.92183,39.89122,{"lat":48,"lon":47},[51,52,53,54],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},{"name":35,"role":31,"phone":32,"phoneExt":23,"email":33},{"name":26,"role":27,"phone":23,"phoneExt":23,"email":23},{"name":55,"role":27,"phone":23,"phoneExt":23,"email":23},"Kevin Lambrese, PhD",{"type":57,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100545132","investigating-micro-manipulation-procedures-for-assisted-hatching-timing-100545132",false,"NCT06377917","Investigating Micro-Manipulation Procedures for Assisted Hatching Timing","The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing","IMPACT","Inclusion Criteria for participants:\n\n1. Patients undergoing an IVF cycle with plan for subsequent FET of a single euploid embryo\n2. \\\u003C4 2PNs prior to randomization\n3. Female partners age \\\u003C42 years old at start of VOR cycle\n4. Normal ovarian reserve:\n\n   1. AMH ≥ 1.2 ng\u002FmL\n   2. AFC ≥ 8\n   3. FSH ≤ 12IU\u002FL\n5. BMI \\\u003C38\n6. Patients who desire to transfer the best quality embryo for their embryo transfer.\n\nExclusion Criteria for participants:\n\n1. All patients who do not voluntarily give their written consent for participation\n2. Patients with a prior failed IVF cycle - defined as no blastocysts\n3. Patients with a history of more than one failed euploid embryo transfer\n4. Donor oocyte cycles\n5. Gestational Carriers\n6. Male partner with \\\u003C100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)\n7. Use of surgical procedures to obtain sperm\n8. Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer\n9. Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \\\u003C6mm,), or persistent endometrial fluid\n10. Single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis than standard PGT-A","FEMALE","18 Years","42 Years",{"count":70,"type":71},75,"ESTIMATED","INTERVENTIONAL",[74],"NA","This study aims to assess the clinical significance of cleavage stage (Day 3) assisted hatching compared to assisted hatching at the blastocyst stage (Day 5,6,7) of embryo development at the time of trophectoderm (TE) biopsy for patients undergoing in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A) for treatment of their infertility.",[77],"Infertility","2026-06-01",{"date":80,"type":81},"2026-06-03","ACTUAL",{"date":83,"type":81},"2026-05-31",{"date":85,"type":71},"2028-05-31",{"name":5,"class":6},1]