An interventional study of Laser Assisted Hatching in Infertility, sponsored by Reproductive Medicine Associates of New Jersey. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Reproductive Medicine Associates of New Jersey · Not applicable, Interventional, and Other
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 75 is below the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Reproductive Medicine Associates of New Jersey is the lead sponsor of 55 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Normal ovarian reserve:
Exclusion Criteria for participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser.
Other: Laser Assisted Hatching
Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser.
Other: Laser Assisted Hatching
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
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
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 12 months is below that.
Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Reproductive Medicine Associates of New Jersey