Validation of the AndroWash Automated System for Standardized and Efficient Sperm Preparation in Assisted Reproductive Technology

Sperm preparation is a critical, yet highly operator-dependent, step in Assisted Reproductive Technology (ART) workflows, often leading to variability in Total Motile Sperm Count (TMSC) recovery and prolonged processing times. The AndroWash automated system was developed to address these limitations by standardizing the density gradient centrifugation process. This study aimed to validate the performance of the AndroWash system against conventional manual sperm washing across five critical user-need claims: reduced operator errors and variability, faster and easier gradient layering, preservation of sperm quality (motility and DNA integrity), standardized discard step, and reduced end-to-end processing time. A comparative validation study was conducted involving ten operators (five novice, five expert), each performing multiple trials with both the conventional manual method and the AndroWash system. Key metrics included error rate, TMSC coefficient of variation (CV), System Usability Scale (SUS) score, layering time, post-wash progressive motility, DNA Fragmentation Index (DFI), and total workflow time. AndroWash demonstrated significant superiority across all claims. It reduced the mean error rate by approximately 73.0% and halved the TMSC CV from 17.91% to 10.60%. Layering time was reduced by 5x (from 10.0 min to 2.0 min), with a corresponding increase in user-perceived ease of use. Post-wash progressive motility was higher with AndroWash (86.84% vs. 78.58% for conventional), and DFI was lower (4.4% vs. 5.3%), indicating superior sperm quality preservation. The total end-to-end processing time was reduced by 44%, from 35.5 minutes to 19.8 minutes. The AndroWash automated system provides a reliable, efficient, and user-friendly alternative to conventional sperm preparation methods. Its ability to minimize operator-induced variability, preserve sperm quality, and significantly reduce workflow time supports its adoption as a new standard for sperm preparation in clinical ART settings.