Alife Health (Alife), the leading technology company advancing artificial intelligence (AI) tools for in-vitro fertilization (IVF) in the US, today announced the completion of the first US randomized control trial (RCT) to evaluate the impact of AI in embryo selection. This groundbreaking study marks a significant milestone in reproductive health, with results expected to provide key insights into improving IVF success rates.

The trial enrolled 440 patients at seven clinics across the US between June 2022 and October 2024. Participants, aged 21 to 43 and undergoing autologous IVF treatment, were randomized in a 1:1 ratio to either a treatment group using AI-assisted embryo selection (AI + morphology grading) or a control group using traditional morphology grading alone.

The primary objective of the study was to evaluate the ongoing pregnancy rate (pregnancy defined as fetal heartbeat at 6–8 weeks) with the adjunctive use of AI to select embryos for transfer compared to standard morphology grading alone. ​​ Alife’s investigational AI system was specifically developed to analyze static images of day 5, 6, and 7 blastocyst-stage embryos, assessing their likelihood of resulting in an ongoing pregnancy. This system serves as a supportive tool for embryologists, providing additional data to help optimize embryo selection and improve IVF success.

“We are thrilled to have completed this pivotal study, which we believe will be a game-changer in the IVF space,” said Melissa Teran, CEO of Alife Health. “Our AI software tool was designed to automate embryo grading and selection for embryologists, and we believe this trial will represent a significant step toward further validating the power of AI in improving patient outcomes.”

Final data analysis is expected in April 2025, with results anticipated to provide valuable insights into the role of AI in IVF. Alife continues to push the boundaries of fertility care through data-driven, AI-powered tools aimed at improving patient outcomes and democratizing access to advanced fertility treatment.