The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
Reproductive Medicine Associates of New Jersey
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.
Description
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.
Eligibility
- Age range
- 18–42 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria for participants: 1. Patients undergoing an IVF cycle with plan for subsequent FET of a single euploid embryo 2. \<4 2PNs prior to randomization 3. Female partners age \<42 years old at start of VOR cycle 4. Normal ovarian reserve: 1. AMH ≥ 1.2 ng/mL 2. AFC ≥ 8 3. FSH ≤ 12IU/L 5. BMI \<38 6. Patients who desire to transfer the best quality embryo for their embryo transfer. Exclusion Criteria for participants: 1. All patients who do not voluntarily give their written consent for participation 2. Patients with a prior failed IVF cycle - defined as no blastocysts 3…
Interventions
- OtherLaser Assisted Hatching
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
Location
- Reproductive Medicine Associates of New JerseyMarlton, New Jersey