Deep learning versus manual morphology-based embryo selection in IVF: a randomized, double-blind noninferiority trial
To assess the value of deep learning in selecting the optimal embryo for in vitro fertilization, a multicenter, randomized, double-blind, noninferiority parallel-group trial was conducted across 14 in vitro fertilization clinics in Australia and Europe. Women under 42 years of age with at least two early-stage blastocysts on day 5 were randomized to either the control arm, using standard morphological assessment, or the study arm, employing a deep learning algorithm, intelligent Data Analysis Score (iDAScore), for embryo selection. The primary endpoint was a clinical pregnancy rate with a noninferiority margin of 5%. The trial included 1,066 patients (533 in the iDAScore group and 533 in the morphology group). The iDAScore group exhibited a clinical pregnancy rate of 46.5% (248 of 533 patients), compared to 48.2% (257 of 533 patients) in the morphology arm (risk difference -1.7%; 95% confidence interval -7.7, 4.3; P = 0.62). This study was not able to demonstrate noninferiority of deep learning for clinical pregnancy rate when compared to standard morphology and a predefined prioritization scheme. Australian New Zealand Clinical Trials Registry (ANZCTR) registration: 379161 .
Authors
- Robert Lahoud
- Jørgen Berntsen (ORCID: https://orcid.org/0000-0002-5976-1002)
- Peter Illingworth (ORCID: https://orcid.org/0009-0008-1319-6643)
- Rebecca L. Kelley
- Thorir Hardarson (ORCID: https://orcid.org/0000-0002-3339-1744)
- Lyndsey Zujovic
- Scott McGill Nelson (ORCID: https://orcid.org/0000-0002-9099-3047)
- Geoffrey Trew (ORCID: https://orcid.org/0000-0001-8329-7513)
- Saran Ahitan
- Susanne Wennerström
- Johnny Hindkjær
- David K. Gardner (ORCID: https://orcid.org/0000-0003-3138-8274)
- Christos Venetis (ORCID: https://orcid.org/0000-0001-9591-7222)
- Park Hannah
- Aisling Ahlström (ORCID: https://orcid.org/0000-0002-5074-912X)
- Anthony N. Price (ORCID: https://orcid.org/0000-0002-6907-7554)
- Manveen Mangat
- Kristy Demmers
- Fleur Cattrall
- Yee Shan Lisa Lee (ORCID: https://orcid.org/0000-0002-0778-9636)
- Anna Vincent
- Bettina Troest (ORCID: https://orcid.org/0000-0002-7556-7568)
- Anette Gabrielsen (ORCID: https://orcid.org/0000-0002-7632-6299)
- Mark G. Larman
- Simon Cooke
- Franca Agresta
- Charlotte Knight
Institutions
- The University of Melbourne (AU)
- Aristotle University of Thessaloniki (GR)
- Aalborg University Hospital (DK)
- Sahlgrenska University Hospital (SE)
- Myer Foundation (AU)
- UNSW Sydney (AU)
- Moesgaard Museum (DK)
- Regional Hospital Horsens (DK)
- Vitrolife (Sweden) (SE)
- Australian Centre for HIV and Hepatitis Virology Research (AU)
- Oxford Fertility (GB)
- Imperial College London (GB)
- University of Glasgow (GB)
Publication Details
- Journal
- Nature Medicine
- Published
- 2024-08-09
- DOI
- https://doi.org/10.1038/s41591-024-03166-5
- Citations
- 73
- Primary Topic
- Reproductive Biology and Fertility
- Type
- article
- Field-Weighted Citation Impact
- 39.63