Artificial Intelligence in Embryo Selection in Assisted Reproduction for Embryos Cultured to the Fifth Day of Development

NCT07844083 | Recruiting DMC

• 1 other identifier: RBHP 2023 BRUGNON
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Embryo selection is one of the major challenges in Assisted Reproductive Technology (ART) in order to continuously improve clinical pregnancy rates. Morphological evaluation of embryos is the standard method used to assess embryo quality and to select the embryo to be transferred. However, this observational method has limitations: it can be subjective and may lead to inter- and intra-observer variability. To increase pregnancy rates, the transfer of two embryos may be proposed, which can result in high-risk multiple pregnancies. Despite the introduction of time-lapse systems and embryo selection algorithms aimed at increasing live birth rates, outcomes in ART remain suboptimal and can still be improved. The use of artificial intelligence (AI) is expanding in the medical field and is increasingly being applied in ART laboratories to optimize outcomes while avoiding multiple pregnancies. EMA™ is a secure artificial intelligence software platform developed by the company AiVF. The use of this software could allow a standardized and reproducible evaluation of embryo development up to the fifth day of embryonic culture. Through the application of an algorithm, the software may enable the selection of the embryo with the highest potential for achieving pregnancy. The primary objective of this study is to evaluate the use of the EMA™ artificial intelligence system in embryo selection for embryos cultured up to day 5, in comparison with the morphokinetic criteria currently used in the laboratory for the first fresh transfer of a day-5 embryo. The secondary objectives are to assess whether artificial intelligence (1) reduces the time to achieve pregnancy (defined as pregnancy achieved or not after the first transfer of a day-5 embryo) and (2) affects the miscarriage rate among patients treated in the ART CECOS unit. A medico-economic analysis will be conducted to evaluate the number of new patients undergoing an additional treatment attempt and to determine whether there is a correlated reduction in time to pregnancy by assessing the number of pregnancies achieved after the first transfer in patients already under treatment. A cost-effectiveness analysis will also be performed, comparing the cost-effectiveness ratios between the two study arms.

Conditions

Infertility

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

  To evaluate the use of EMA artificial intelligence in embryo selection for embryos cultured through day 5, in comparison with the morphokinetic criteria (gardner classification) used in the laboratory for the first fresh transfer of an embryo cultured through day 5 of development. Gardner classification : The three blastocyst parameters will be assessed independently: the degree of blastocyst expansion, the quality of the inner cell mass, and the quality of the trophectoderm. These three parameters will then be pooled to generate an overall blastocyst classification.

  5 days

Secondary Outcomes (2)

• Impact of AI on time to obtain a pregnancy

  up to 6 weeks

• Impact of AI on miscarriage rates

  up to 6 weeks

Study Arms (2)

Manual procedure

NO INTERVENTION

The embryo to be transferred on day 5 is selected by the biologist.

Artificial intelligence

EXPERIMENTAL

The embryo to be transferred on day 5 is selected by the artificial intelligence software

Device: EMA

Interventions

EMA DEVICE

Embryo selection on the 5th day of culture is performed using artificial intelligence

Artificial intelligence

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First attempt at assisted reproductive technology (ART) treatment using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
• Treatment for primary infertility of idiopathic or male origin, for single women or female couples
• Use of fresh sperm from the partner or frozen donor sperm
• Embryo culture up to the 105th hour of development (the time at which the score is assigned when selecting the embryo to be transferred to the uterus on the 5th day of development (D5))
• First transfer of a fresh embryo on the 5th day of culture
• Known Implantation Data (KID) (= clinical pregnancy confirmed by the presence of a heartbeat at 6 weeks via ultrasound)

You may not qualify if:

• Use of frozen sperm from the spouse
• No oocytes retrieved during oocyte retrieval
• No blastocysts obtained on the 5th day of development
• Embryo culture with transfer on the 2nd or 3rd day of development

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63001, France

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Laure Chaput, PharmD, PhD

  ART unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 28, 2026
• Study Start: November 4, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

FR (1)