[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06377917":3,"trial-entities:NCT06377917":105,"trial-summary:NCT06377917":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":74,"locations":76,"central_contacts":98,"overall_officials":101,"references":103,"see_also_links":104},"NCT06377917","2304-BRG-057-JF","Investigating Micro-Manipulation Procedures for Assisted Hatching Timing","The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing","RECRUITING","2028-05-31","2026-06","2026-06-03","2026-05-31","Reproductive Medicine Associates of New Jersey","OTHER",false,"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.","The proposed study aims to perform a split cohort study where each patient's cohort of fertilized zygotes, (two pronuclei or 2PNs) is split into two groups and randomized, thus allowing each patient to serve as their own control and decreasing confounding variables. Half of the cohort will proceed with the current standard of day 3 or cleavage assisted hatching and the other half of the cohort will receive the sequential hatching and trophectoderm biopsy procedure at the blastocyst stage of embryo development.",[19],"Infertility",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},75,"ESTIMATED",[28],{"type":14,"name":29,"description":30,"armGroupLabels":31},"Laser Assisted Hatching","Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.",[32,33],"Blastocyst Stage Assisted Hatching (AH)","Cleavage Stage Assisted Hatching (AH)",[35],{"measure":36,"description":37,"timeFrame":38},"Blastulation Rate","Blastulation rate per 2 pronuclei (PN) in each group","1 week after vaginal oocyte retrieval (VOR)",[40,44,47,51,55,59,63],{"measure":41,"description":42,"timeFrame":43},"Embryo morphologic grade","Gardner and Modified Gardner grading system will be used","1 week post VOR",{"measure":45,"description":46,"timeFrame":43},"Timing of blastulation","proportion of blastocysts that blastulate on day 5,6 or 7",{"measure":48,"description":49,"timeFrame":50},"Aneuploidy rate","Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results","2 weeks post blastulation",{"measure":52,"description":53,"timeFrame":54},"Positive pregnancy rate","proportion of positive pregnancy tests per embryo transfer","approximately 9 days post embryo transfer",{"measure":56,"description":57,"timeFrame":58},"Sustained implantation rate","proportion of patients discharged with presence of a fetal heartbeat","8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer",{"measure":60,"description":61,"timeFrame":62},"Pregnancy loss rate","proportion of pregnancy patients who experience a loss of pregnancy","approximately 1-2 months post initial bHCG",{"measure":64,"description":65,"timeFrame":66},"Live birth rate","proportion of patients who deliver a live born infant","approximately 40 weeks gestation or 7 months post discharge","FEMALE","18 Years","42 Years",{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"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",[75],"ADULT",[77],{"facility":13,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":95},"Marlton","New Jersey","08053","United States",[83,88,90,93],{"name":84,"role":85,"phone":86,"email":87},"Christine V Whitehead, MS, BSN, RN","CONTACT","19736562841","clinicalresearchteam@ivirma.com",{"name":89,"role":85,"phone":86,"email":87},"Caroline Zuckerman, BS, RN",{"name":91,"role":92},"Jason Fransiak, MD","PRINCIPAL_INVESTIGATOR",{"name":94,"role":92},"Kevin Lambrese, PhD",{"lat":96,"lon":97},39.89122,-74.92183,[99,100],{"name":84,"role":85,"phone":86,"email":87},{"name":89,"role":85,"phone":86,"email":87},[102],{"name":91,"affiliation":13,"role":92},[],[],{"nct_id":4,"conditions":106,"biomarkers":107},[19],[],{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study planning to enroll 75 participants. Each participant's fertilized eggs will be split into two groups, with one group receiving Day 3 assisted hatching and the other receiving Day 5, 6, or 7 assisted hatching.","completed","Investigating Assisted Hatching Timing for Infertility Treatment","This study is looking at the best time to perform Laser Assisted Hatching, a procedure used in in vitro fertilization (IVF) to help an embryo implant. Researchers are comparing performing this procedure on Day 3 (cleavage stage) versus Day 5, 6, or 7 (blastocyst stage) of embryo development. The goal is to see if timing affects the \"blastulation rate\" (how often embryos develop into blastocysts), measured one week after egg retrieval. You may be able to join if you are a woman between 18 and 42 years old, undergoing IVF with a plan for a frozen embryo transfer, and meet specific criteria for ovarian health and BMI. The study's current status is unclear.","The primary outcome, blastulation rate, is measured one week after vaginal oocyte retrieval (VOR).",113,"Not specified in the trial record.","Not stated in the trial record.",[29],"v2"]