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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06454058
Other study ID # INC-IIS-2024-004
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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