Deep learning versus manual morphology-based embryo selection in IVF: a randomized, double-blind noninferiority trial
Peter Illingworth, Christos Venetis, David K. Gardner, Scott M. Nelson, Jørgen Berntsen, Mark G. Larman, Franca Agresta, Saran Ahitan, Aisling Ahlström, Fleur Cattrall, Simon Cooke, Kristy Demmers, Anette Gabrielsen, Johnny Hindkjær, Rebecca L. Kelley, Charlotte Knight, Yee Shan Lisa Lee, Robert Lahoud, Manveen Mangat, Park Hannah, Anthony N. Price, Geoffrey Trew, Bettina Troest, Anna Vincent, Susanne Wennerström, Lyndsey Zujovic, Thorir Hardarson
Abstract
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 .