Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

Part of paid clinical trials in Marlton, New Jersey.

Sponsor
Reproductive Medicine Associates of New Jersey
Study ID
NCT06377917
Status
Recruiting

Conditions

  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

Interventions

  • Laser Assisted Hatching — OTHER
    Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Blastulation Rate [ Time Frame: 1 week after vaginal oocyte retrieval (VOR) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Reproductive Medicine Associates of New JerseyMarltonNew Jersey08053
Christine V Whitehead, MS, BSN, RN
19736562841
Caroline Zuckerman, BS, RN
19736562841
Jason Fransiak, MD (PRINCIPAL_INVESTIGATOR)
Kevin Lambrese, PhD (PRINCIPAL_INVESTIGATOR)

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