Rationale and study design of a double-blinded prospective randomized clinical trial comparing euploidy rates among embryos created from sibling oocytes injected with sperm processed by microfluidics or by density gradient centrifugation.

Background: During the in vitro fertilization (IVF) process, sperm must be processed prior to insemination. While the most common method, density gradient centrifugation, can potentially damage sperm during centrifugation, a recent advancement in sperm processing uses a microfluidics system which selects for the most highly motile sperm. In selecting for these sperm which may be of higher quality, the euploidy rates of embryos created as a result may also be improved. The primary aim of this study is to compare the euploidy rates per mature oocyte between embryos created from sibling oocytes injected with sperm processed by microfluidics sorting or by density gradient centrifugation.

Methods: This is a double-blinded prospective randomized sibling oocyte study including patients undergoing treatment with IVF with intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT). After controlled ovarian hyperstimulation, oocytes from each patient will be separated into two groups. Each group will be randomized to sperm processed using either microfluidics or density gradient centrifugation and embryos biopsied for PGT to assess euploidy rates. A sample size of 686 oocytes in each group for a total of 1372 oocytes will provide 80% power to detect a significant difference in the euploidy rates per mature oocyte between the two groups. An ancillary study examining the relationship between sperm processing method and sperm DNA fragmentation will be assessed.

Conclusion: This study will offer insight into the sperm's contribution to embryo euploidy, and has the potential to provide an alternative method of improving euploidy rates in clinical practice.