Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377917
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
Sponsor:
Reproductive Medicine Associates of New Jersey
Organization:
Reproductive Medicine Associates of New Jersey
Study Overview
Official Title:
The IMPACT Trial Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT
Brief 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 567 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None