NCT06454058

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

June 6, 2024

Last Update Submit

July 16, 2025

Conditions

Keywords

Advanced Maternal AgeEmbryo Grade

Outcome Measures

Primary Outcomes (1)

  • Embryo Grade

    Embryo grade for PGT-A confirmed euploid embryos

    6 months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inception Fertility Research Institute, LLC

Houston, Texas, 77081, United States

Location

Related Publications (1)

  • Vitagliano A, Paffoni A, Vigano P. Does maternal age affect assisted reproduction technology success rates after euploid embryo transfer? A systematic review and meta-analysis. Fertil Steril. 2023 Aug;120(2):251-265. doi: 10.1016/j.fertnstert.2023.02.036. Epub 2023 Mar 5.

    PMID: 36878347BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 12, 2024

Study Start

June 7, 2024

Primary Completion

March 26, 2025

Study Completion

March 26, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations