The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 42
Healthy Volunteers: f
View:
• Patients undergoing an IVF cycle with plan for subsequent FET of a single euploid embryo
• \<4 2PNs prior to randomization
• Female partners age \<42 years old at start of VOR cycle
• Normal ovarian reserve:
‣ AMH ≥ 1.2 ng/mL
⁃ AFC ≥ 8
⁃ FSH ≤ 12IU/L
• BMI \<38
• Patients who desire to transfer the best quality embryo for their embryo transfer.
Locations
United States
New Jersey
Reproductive Medicine Associates of New Jersey
RECRUITING
Marlton
Contact Information
Primary
Christine V Whitehead, MS, BSN, RN
clinicalresearchteam@ivirma.com
19736562841
Backup
Caroline Zuckerman, BS, RN
clinicalresearchteam@ivirma.com
19736562841
Time Frame
Start Date: 2026-05-31
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 75
Treatments
Other: Cleavage Stage Assisted Hatching (AH)
Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser.
Experimental: Blastocyst Stage Assisted Hatching (AH)
Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser.
Related Therapeutic Areas
Sponsors
Leads: Reproductive Medicine Associates of New Jersey