An automatic semen processing system versus a manual method for semen processing: a randomized, single-blind non-inferiority trial.

BACKGROUND: In assisted reproductive technology (ART) laboratories, semen processing is traditionally performed using manual density gradient centrifugation (DGC), which is labor intensive, time consuming, and subject to inter-technician variability. This study aimed to evaluate the effectiveness and repeatability of an automatic semen processing system (Avensen (Shenzhen) Medical Tech Co., Ltd., Shenzhen, China) compared with the standard manual method. METHODS: A total of 110 eligible male participants (aged 18-45 years) were enrolled. Each semen sample was randomized into three 1-mL aliquots, of which two were processed automatically (automated groups 1 and 2) and one manually (manual group). Independent t-tests were used to compare the progressively motile sperm recovery rate between the automated and manual groups. System repeatability was assessed between the two automated groups using the intraclass correlation coefficient, the coefficient of variation, and Bland-Altman analysis. RESULTS: The automatic system was non-inferior to the manual method in terms of the primary outcome. The progressively motile sperm recovery rate were 42.26% and 42.40% in automated groups 1 and 2, respectively, versus 41.64% in the manual group. The lower 95% confidence limits were -1.39% and -1.37%, both exceeding the -6% non-inferiority margin. Post-processing percentage of progressively motile sperm (PR%) was significantly higher in both automated groups: 62.06% and 62.63% versus 58.83% (P<0.001). No significant differences were found in sperm concentration or total motile count (P>0.05). Repeatability was excellent: the recovery rate had an intraclass correlation coefficient of 0.95 (95% CI: 0.93-0.97) and a mean coefficient of variation of 10.87%. Correlation analysis (r=0.9092), Deming regression (slope=1.0277), and Bland-Altman analysis (mean difference -0.1448%, 95.41% within limits) indicated strong agreement without bias. CONCLUSION: The investigated automatic semen processing system is non-inferior to the standard manual method in terms of the progressively motile sperm recovery rate, and the results show high repeatability and consistency. The automatic semen processing system can help technicians reduce their workload, improve work efficiency, and better meet clinical needs. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=274183, identifier ChiCTR2500105131.