Received July 07, 2024
Accepted November 25, 2024

Objective: Clinical validation of sperm selection device ZyMōtâ„¢ for standard IVF. Methods: The pre-clinical validation of ZyMōtâ„¢ included several steps. First, split semen preparation compared density gradient centrifugation (DGC) to ZyMōtâ„¢ with primary outcome fraction and absolute number of progressive motile sperm. Second, sibling oocytes were fertilized with sperms prepared with DGC and sperms selected by ZyMōtâ„¢, primary endpoint fertilization rate, utility rate, embryo development pace quality. After this, DGC was replaced by ZyMōtâ„¢, first without centrifugation steps, and then with a five-minute centrifugation step and subsequent media change prior to gamete co-incubation. Endpoint was assessment of key performance indicators against previous results using DGC for standard IVF. Results: ZyMōtâ„¢ resulted in purer sperm selection compared to DGC (fraction progressive motile sperm 97.2±3.1% vs. 83.0±14.1%, p<0.01). Fertilization of sibling oocytes resulted in similar fertilization rates and utility rates, and no differences in embryo development pace or quality. However, after changing sperm selection protocol from DGC to ZyMōtâ„¢ for standard IVF for all fresh semen samples with motile sperm, the fertilization rates and utility rates were significantly reduced, and cases of total failure of fertilization increased substantially. Adding five-minute centrifugation and media change after centrifugation to the sperm selection protocol restored fertilization rate, including total failure of fertilization rate, to normal. Conclusions: To conclude, the ZyMōtâ„¢ sperm selection device is suitable for standard IVF only after inclusion of five minutes centrifugation and subsequent media change prior to gamete co-incubation.