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 — OTHERRoutine 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
- Christine V Whitehead, MS, BSN, RN19736562841
- Caroline Zuckerman, BS, RN19736562841
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Reproductive Medicine Associates of New Jersey | Marlton | New Jersey | 08053 | Jason Fransiak, MD (PRINCIPAL_INVESTIGATOR) Kevin Lambrese, PhD (PRINCIPAL_INVESTIGATOR) |
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