Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629766
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
The EPIC Study Exploring Paternal Age and the Influence on Blastocyst Culture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The EPIC Study Exploring Paternal Age and the Influence on Blastocyst Culture
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC
Brief Summary:
This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices Zymot compared to routine embryologist selected sperm after density gradient centrifugation DGC preparation for intracytoplasmic sperm injection ICSI in patients undergoing in vitro fertilization treatment IVF of their infertility
Detailed Description:
In this study we aim to determine the clinical utility of the Zymot sperm selection methodology for ICSI while also accounting for paternal age This study will be a prospective split cohort randomized control trial comparing the routine standard of DGC sperm preparation for ICSI versus sperm prepared via Zymot for ICSI Embryology parameters ploidy status DNA fragmentation and clinical pregnancy outcomes will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None