Reproductive Medicine Associates of New Jersey
Marlton, New Jersey, 08053, United States
Location status: Recruiting
NCT Number: NCT06377917
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.
Interested in participating?
Request Info18 year–42 year
Female
Interventional
Not applicable
Marlton, New Jersey, 08053, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for participants:
Exclusion criteria
for participants:
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
Time frame: 1 week after vaginal oocyte retrieval (VOR)
Blastulation rate per 2 pronuclei (PN) in each group
Time frame: 1 week post VOR
Gardner and Modified Gardner grading system will be used
Time frame: 1 week post VOR
proportion of blastocysts that blastulate on day 5,6 or 7
Time frame: 2 weeks post blastulation
Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results
Time frame: approximately 9 days post embryo transfer
proportion of positive pregnancy tests per embryo transfer
Time frame: 8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer
proportion of patients discharged with presence of a fetal heartbeat
Time frame: approximately 1-2 months post initial bHCG
proportion of pregnancy patients who experience a loss of pregnancy
Time frame: approximately 40 weeks gestation or 7 months post discharge
proportion of patients who deliver a live born infant
Interested in participating?
Request InfoReproductive Medicine Associates of New Jersey
Other
The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
Acronym: IMPACT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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