Developing an AI Tool to Analyze Sperm Samples and Predict Fertility Outcomes in IVF and ICSI Treatments

What this Trial Is About

Researchers are conducting a prospective, multicenter observational study to develop an artificial intelligence platform that analyzes sperm samples and predicts their clinical potential in the context of infertility and IVFICSI treatments. The study involves 500 semen samples analyzed in vitro over a 24-month period, aiming to improve understanding of sperm quality and reproductive outcomes. Sperm samples will be processed using three different techniques swim-up, density gradient centrifugation, and HyperSperm. The study includes two groups based on IVFICSI cycles those using ejaculated partner semen and those using donor semen. No interventions are administered to participants instead, semen samples are analyzed to build and test AI models. Participants provide semen samples during their IVFICSI cycles, and researchers will evaluate the AI platforms predictive performance for reproductive outcomes, measured up to confirmation of clinical pregnancy approximately 6 to 8 weeks after embryo transfer. The study is led by Fecundis Lab SL and will continue until early 2028, with participants involved during their treatment cycles and sample collection periods.

Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential