Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-02 @ 1:23 AM
Study NCT ID:
NCT06454058
Status:
TERMINATED
Last Update Posted:
2025-07-20
First Post:
2024-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Euploid Embryo Grade and Maternal Age
Sponsor:
Inception Fertility Research Institute, LLC
Organization:
Study Overview
Official Title:
Association Between Euploid Embryo Grade and Maternal Age, a Retrospective Cross-sectional Study
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Preliminary findings of inconsistent embryo grading across sites.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background: Advanced maternal age (AMA) is associated with a reduction in live birth rate (LBR) after ART cycles. The main reason for this reduction is the lower number of oocytes aspirated, the number of developing embryos and the low number of euploid embryos available for transfer. The impact of age on success rates after the transfer of an euploid embryo has been a matter of discussion, with a recent meta-analysis showing a reduction in LBR after the transfer of an euploid blastocyst to women of AMA (1). There could be many reasons for this reduced LBR but they can be categorized into two broad categories - the uterus (including the mother's health) and the embryo (including the oocyte and the sperm).
It is possible that factors associated with reduced embryo quality would manifest in a lower embryo grade.
It is possible that factors associated with reduced embryo quality would manifest in a lower embryo grade.
Detailed Description:
Objective: To study if there is an association between advanced maternal age and lower embryo grading of euploid embryos.
Hypothesis: Advanced maternal age is associated with a lower embryonic grade in euploid embryos.
Study Design: This is a retrospective cross-sectional study of euploid embryos from patients who have completed IVF with PGT-A testing at a fertility clinic in The Prelude Network (US sites only). A comparison of embryo grade between different age groups (\<35, 40+) will be done after controlling for baseline demographic characteristics.
Hypothesis: Advanced maternal age is associated with a lower embryonic grade in euploid embryos.
Study Design: This is a retrospective cross-sectional study of euploid embryos from patients who have completed IVF with PGT-A testing at a fertility clinic in The Prelude Network (US sites only). A comparison of embryo grade between different age groups (\<35, 40+) will be done after controlling for baseline demographic characteristics.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: