NCT06377917

Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Reproductive Medicine Associates of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Infertility

Interventions

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

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2024-04-22
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States