Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602687
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
PICSI Impact on Euploidy in Assisted Reproduction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sperm Hyaluronic Binding Selection PICSI Impact on Embryo Aneuploid Status in Assisted Human Reproduction
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Hyaluronic acid HA is a major component of the cumulus complex surrounding oocytes Intracytoplasmic sperm injection ICSI involves injection of a selected sperm into the oocyte Embryologists select sperm with normal morphology and progressive motility Physiologic intracytoplasmic sperm injection PICSI involves sperm selection for ICSI based on hyaluronan binding Mature sperm which bind to HA have greater genomic integrity and reduced levels of DNA fragmentation Earlier observational studies demonstrated improved outcomes in assisted reproductive technologies ART including improved clinical pregnancy rates decreased miscarriage rates and higher live birth rates A large multicentre randomized trial the HABSelect trial which included over 2500 couples found that PICSI did not improve term 37 weeks gestation live birth rates compared to standard ICSI However mechanistic analysis of the data from the HABSelect trial showed a significant reduction in miscarriage rates most notable in couples where the woman was aged over 37 years where a significant reduction in miscarriage rate was seen 40 with ICSI vs 15 with PICSI A 2021 retrospective sibling oocyte study including 45 cycles compared fertilisation and embryo development and found higher fertilisation rate in PICSI cycles No difference was observed in clinical pregnancy rates miscarriage rates and live birth rates were not reported We aim to prospectively study PICSI vs standard ICSI in sibling oocytes to investigate if PICSI improves embryological and ART outcomes particularly fertilisation rate embryo euploid status and miscarriage rate where the female patient is aged over 35 years
Detailed Description:
None
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