Non-interventional study comparing sibling oocytes cultured in two continuous media: a putative workflow for the evidence-based implementation of a newly commercialized IVF culture media

Abstract Research Question To propose a design for the evidence-based implementation of a novel commercially-available continuous IVF culture medium in compliance with an efficient quality-management-system. Design A practical example is provided via a non-interventional study on sibling oocytes. All ICSI cycles with ejaculated-sperm performed by women Results 181 cohorts of sibling oocytes were included. Geri-medium (n=631 oocytes) and CSCM (n=643 oocytes) resulted in similar blastulation rates (mean±SD: 42.8%±30.1% versus 43.1%±29.0%; Wilcoxon-signed-rank-test=0.8). The blastocysts cultured in the former (n=275 versus 277) showed longer timings during preimplantation development and were of a poorer-quality (26% versus 18%). Among the PGT-A cycles (n=113), no difference was reported in the euploidy rate (49% of 237 versus 47% of 249 blastocysts). The ongoing-implantation-rate was comparable in the study arms after either euploid (n=29/46, 63% versus n=14/34, 41%) or untested (n=12/31, 39% versus n=7/18, 39%) transfers. Conclusion The blastulation rate among cohorts of sibling oocytes cultured in the same incubator is a fast, reliable and comprehensive performance indicator to internally-validate a novel commercially-available culture medium. The media tested here were considered similarly-efficient in our laboratory. The differences in blastocyst morphology and developmental timings warrant further investigation, although euploidy and ongoing implantation rates were similar.