Microfluidic preparation of spermatozoa for ICSI produces similar embryo quality to density-gradient centrifugation: a pragmatic, randomized controlled trial.

<bold>Study Question: </bold>Does processing of spermatozoa for IVF with ICSI by a microfluidic sperm separation device improve embryo quality compared with density-gradient centrifugation?<bold>Summary Answer: </bold>Patients randomized to microfluidic sperm preparation had similar cleavage- and blastocyst-stage embryo quality and clinical and ongoing pregnancy rates to those who underwent standard sperm processing for IVF with ICSI.<bold>What Is Known Already: </bold>Microfluidic sperm preparation can isolate spermatozoa for clinical use with minimal DNA fragmentation but with unclear impact on clinical outcomes.<bold>Study Design, Size, Duration: </bold>A prospective randomized controlled trial of 386 patients planning IVF from June 2017 through September 2021 was carried out.<bold>Participants/materials, Setting, Methods: </bold>One hundred and ninety-two patients were allocated to sperm processing with a microfluidic sperm separation device for ICSI, while 194 patients were allocated to clinical standard density-gradient centrifugation (control) at an academic medical centre.<bold>Main Results and the Role Of Chance: </bold>In an intention to treat analysis, there were no differences in high-quality cleavage-stage embryo fraction [66.0 (25.8)% control versus 68.0 (30.3) microfluidic sperm preparation, P = 0.541, absolute difference -2.0, 95% CI (-8.5, 4.5)], or high-quality blastocyst fraction [37.4 (25.4) control versus 37.4 (26.2) microfluidic sperm preparation, P = 0.985, absolute difference -0.6 95% CI (-6, 5.9)] between groups. There were no differences in the clinical pregnancy or ongoing pregnancy rates between groups.<bold>Limitations, Reasons For Caution: </bold>The population studied was inclusive and did not attempt to isolate male factor infertility cases or patients with a history of elevated sperm DNA fragmentation.<bold>Wider Implications Of the Findings: </bold>Microfluidic sperm separation performs similarly to density-gradient centrifugation in sperm preparation for IVF in an unselected population.<bold>Study Funding/competing Interest(s): </bold>No external funding to declare. M.P.R. is a member of the Clinical Advisory Board for ZyMōt® Fertility, Inc.<bold>Trial Registration Number: </bold>NCT03085433.<bold>Trial Registration Date: </bold>21 March 2017.<bold>Date Of First Patient’s Enrollment: </bold>16 June 2017. [ABSTRACT FROM AUTHOR]