Association Between Euploid Embryo Grade and Maternal Age

Fertility Clinical Trial

Official title:

Association Between Euploid Embryo Grade and Maternal Age, a Retrospective Cross-sectional Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06454058
• Other study ID #: INC-IIS-2024-004
• Status: Enrolling by invitation
• Start date: June 14, 2024
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Inception Fertility, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: January 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fertility

Locations

Country	Name	City	State
United States	Inception Fertility, LLC	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Inception Fertility, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo Grade	Embryo grade for PGT-A confirmed euploid embryos	6 months