A digitally controlled, remotely operated ICSI system: case report of the first live birth

RESEARCH QUESTION: Can a fully automated, digitally controlled, remotely operated system execute the entire micromanipulation process of intracytoplasmic sperm injection (ICSI)? DESIGN: A workstation automating the 23 micromanipulation steps of ICSI was engineered. The system operated independently under artificial intelligence control or under digital control executed by a remote operator. Pre-clinical validation was conducted with animal models to ensure safety and efficacy. In a clinical application, five donor oocytes intended for the treatment of a 40-year-old patient were fertilized using the automated ICSI system under remote supervision; three additional oocytes were injected manually as controls. Elective single embryo transfers were performed. RESULTS: The automated ICSI system achieved an 80% fertilization rate (n = 4/5), comparable with the manual controls (100%, n = 3/3). Two usable blastocysts were generated in each group. A fresh embryo transfer using an experimental embryo did not result in pregnancy. However, the transfer of a warmed blastocyst from the automated ICSI group resulted in a healthy live birth at 38 weeks of gestation. The system completed 49.6% of the required 115 micromanipulation steps (23 per oocyte) autonomously, and the remaining steps were conducted under digital control by the remote operator. The average time for automated injection of an oocyte was 9 min and 56 s. On-site human intervention was required for the initial set-up, and was needed on one occasion for troubleshooting one of the automated steps. CONCLUSIONS: This study demonstrates the feasibility of fully automated, remotely operated ICSI achieving a live birth. While improvements in autonomy and efficiency are needed, this milestone highlights the potential for automated systems to transform assisted reproductive technology practices globally, enhancing accessibility and standardization.