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Retrospective Evaluation Blastocyst Development by Artificial Intelligency (EBAI)

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Couples or Single Women Undergoing Assisted Reproductive Technology (ART) With IVF/ICSI Techniques Followed by Blastocyst Transfer

Study type

Observational

Funder types

Other

Identifiers

NCT07383480
2023_BRUGNON_retrospectiveEBAI

Details and patient eligibility

About

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.

Full description

This monocentric study analyzes 420 ART cycles from the Clermont-Ferrand University Hospital, conducted between January 2022 and December 2023. It includes IVF/ICSI cycles with embryos cultured in a Time-Lapse Incubator (Geri) and both fresh and frozen blastocyst transfers. A total of 1211 embryos were analyzed, with 619 used to train algorithms for predicting reproductive outcomes. This included 551 single and 34 double embryo transfer cycles, divided into 274 fresh and 345 frozen blastocyst transfers. For all blastocyst-stage embryos, the Geri score, Gardner classification, and EMA score based on time-lapse video were recorded for statistical analysis and evaluation of reproductive outcome predictions

Enrollment

333 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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