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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
75
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
Reproductive Medicine Associates of New Jersey
Marlton, New Jersey, United States
Blastulation Rate
Blastulation rate per 2 pronuclei (PN) in each group
Time frame: 1 week after vaginal oocyte retrieval (VOR)
Embryo morphologic grade
Gardner and Modified Gardner grading system will be used
Time frame: 1 week post VOR
Timing of blastulation
proportion of blastocysts that blastulate on day 5,6 or 7
Time frame: 1 week post VOR
Aneuploidy rate
Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results
Time frame: 2 weeks post blastulation
Positive pregnancy rate
proportion of positive pregnancy tests per embryo transfer
Time frame: approximately 9 days post embryo transfer
Sustained implantation rate
proportion of patients discharged with presence of a fetal heartbeat
Time frame: 8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer
Pregnancy loss rate
proportion of pregnancy patients who experience a loss of pregnancy
Time frame: approximately 1-2 months post initial bHCG
Live birth rate
proportion of patients who deliver a live born infant
Time frame: approximately 40 weeks gestation or 7 months post discharge
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