Prospective randomized controlled study of a microfluidic chip technology for sperm selection in male infertility patients.

The purpose of this study is to evaluate the impact of a microfluidic approach for spermatozoon selection in male infertility patients undergoing intracytoplasmic sperm injection (ICSI). This research enrolled 128 individuals who had ICSI for male-factor infertility. The patients were separated into two groups according to the method used to pick the spermatozoa: group I (n = 64), which used traditional swim-up procedures, and group II (n = 64), which used the Fertile Chip for spermatozoon selection during ICSI therapy. Fertilization rates and embryo quality were the major outcomes. The rates of pregnancy, clinical pregnancy and live birth were used as secondary outcomes. As a result, there was no statistically significant difference between the two groups in terms of fertilization rate, total grade 1 and 2 embryos. Implantation rate was significantly higher in the Fertile Chip group than in the control group (50% vs. 31%, p = 0.02). The Fertile Chip group had considerably greater pregnancy rates, clinical pregnancy rates (CPR) and live birth rates than the control group (62.5% vs. 45.3%, p = 0.038; 59.4% vs. 35.9%, p = 0.006 and 46.8% vs. 25%, p = 0.009). Fertile Chip had no effect on fertilization rates or embryo quality in male-factor infertility couples. However, the Fertile Chip group had a statistically higher pregnancy rate, CPR and live birth rate.