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What is the pregnancy and neonatal outcomes of an interpretable artificial intelligence (AI) model for embryo selection in a prospective clinical trial? This single-centre prospective cohort study was carried out from October 2021 to March 2022. A total of 330 eligible patients were assigned to their preferred groups, with 250 patients undergoing a fresh single-blastocyst transfer cycle after the exclusion criteria had been applied. For the AI-assisted group (AAG), embryologists selected the embryos for transfer based on the ranking recommendations provided by an interpretable AI system, while with the manual group, embryologists used the Gardner grading system to make their decisions. The implantation rate was significantly higher in the AAG than the manual group (80.87% versus 68.15%, P = 0.022). No significant difference was found in terms of monozygotic twin rate, miscarriage rate, live birth rate and ectopic pregnancy rate between the groups. Furthermore, there was no significant difference in terms of neonatal outcomes, including gestational weeks, premature birth rate, birth height, birthweight, sex ratio at birth and newborn malformation rate. The consensus rate between the AI and retrospective analysis by the embryologists was significantly higher for good-quality embryos (i.e. grade 4BB or higher) versus poor-quality embryos (i.e. less than 4BB) (84.71% versus 25%, P < 0.001). These prospective trial results suggest that the proposed AI system could effectively help embryologists to improve the implantation rate with single-blastocyst transfer compared with traditional manual evaluation methods. [ABSTRACT FROM AUTHOR]