Association Between Euploid Embryo Grade and Maternal Age

• Conditions: Fertility

• Registration Number: NCT06454058
• Lead Sponsor: Inception Fertility Research Institute, LLC

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.

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.

Study Timeline

• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Study Start: 2024-06-07
• Study First Posted: 2024-06-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU)
• PGT biopsy was conducted in 2023,
• PGT biopsy was performed on blastocyst stage embryo,
• PGT-A result is euploid.

Exclusion Criteria

• PGT-A result is mosaic,
• Embryos in which PGT-M was done and were found to be carriers of the mutation,
• Embryos in which PGT-SR was done and were found to be carriers of the structural rearrangement.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Embryo Grade	6 months	Embryo grade for PGT-A confirmed euploid embryos

Trial Locations

Locations (1)

Inception Fertility Research Institute, LLC; 🇺🇸 Houston, Texas, United States