Retrospective Evaluation Blastocyst Development by Artificial Intelligency

NCT07383480 | Completed

• 1 other identifier: 2023_BRUGNON_retrospectiveEBAI
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 1

Brief Summary

In assisted reproductive technology (ART), selecting the most viable embryos from a large number of fertilized eggs is crucial. While techniques like morphological assessment, time-lapse monitoring systems, and pre-implantation genetic testing have improved the process, implantation success rates remain limited. The introduction of artificial intelligence in embryo evaluation, such as automated systems like EMA by AIVFTM, provides a promising alternative to enhance the accuracy and effectiveness of embryo selection. This study aims to assess the performance of the EMA system compared to traditional methods by examining its ability to rank embryos based on their potential for successful implantation, with the goal of increasing the chances of a successful pregnancy. This is the first clinical evaluation of this platform in France, offering new opportunities to improve decision-making in in-vitro fertilization.

Conditions

Reproductive Techniques, Assisted; Artificial Intelligence; Embryo Transfer

Keywords

Artificial intelligence; Embryo selection; IVF outcome; Time-lapse monitoring

Outcome Measures

Primary Outcomes (1)

• Comparison of artificial intelligence (AI) Score and Laboratory Embryo Classification

  The study aims to compare the EMA score assigned by the EMA platform (AiVFTM), an artificial intelligence-based tool, with the manual embryo classification performed by embryologists in the laboratory. This manual classification includes morphological assessment using the Gardner grading system and morphokinetic evaluation through the GERI score. The goal is to determine the level of concordance between the AI-generated scores and traditional embryologist assessments, and to evaluate the relationship and possible variability between the EMA score and the manual scoring methods.

  01/01/2022-31/12/2023

Secondary Outcomes (2)

• To determine the association between EMA Score and implantation and live birth rates

  01/01/2022-31/12/2023

• To evaluate the optimal EMA score threshold for maximizing live birth rates

  01/01/2022-31/12/2023

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Couples, single women, or female couples undergoing assisted reproductive technology (ART) with IVF/ICSI techniques followed by blastocyst transfer.

You may qualify if:

• IVF or ICSI treatment between January 2022 and December 2023
• Fresh or frozen sperm from the partner or a donor
• Embryo culture up to the 105th hour
• Fresh or frozen embryo transfer on Day 5
• Known implantation data (clinical pregnancy assessed by the presence of cardiac activity at 6 weeks via ultrasound)

You may not qualify if:

• Epididymal or testicular sperm
• Embryo culture with transfer on Day 2 or Day 3
• ICSI with oocyte donation or the use of thawed oocytes
• Transfer of two embryos resulting in a singleton pregnancy
• No blastocyst obtained on Day 5

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Helping Behavior

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Florence Brugnon

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: April 30, 2025
• Last Updated: February 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)