Abstract
PURPOSE: The debate regarding the predictive value of the sperm DNA fragmentation index (DFI) on assisted reproductive technology (ART) outcomes continues. This study aimed to investigate the impact of sperm DFI on IVF/ICSI outcomes. METHODS: This retrospective cohort study included 4319 patients undergoing 5784 fresh IVF/ICSI cycles from January 2015 to December 2022. Data on clinical characteristics, embryological development, pregnancy, and neonatal outcomes were collected to assess the differences between the DFI ≤ 30% and > 30% groups in IVF/ICSI cycles. RESULTS: The mean (SD) sperm DFI were 10.85 (6.36) % for IVF cycles and 12.96 (7.24) % for ICSI cycles in the DFI ≤ 30% group. Conversely, the mean (SD) DFI were 39.53 (8.83) % for IVF cycles and 42.58 (11.58) % for ICSI cycles in the DFI > 30% group. No significant differences were observed between the DFI ≤ 30% and > 30% groups in 2PN fertilization rate, blastocyst formation rate, implantation rate, clinical pregnancy rate, live birth rate, and miscarriage rate (P > 0.05). A total of 1471 neonates were followed, and the incidence of congenital malformations was comparable across the two groups (P > 0.05). Multivariable analyses showed male age significantly associated with sperm DFI. Compared with men aged < 35 years, those aged 35-45 and > 45 years had higher DFI risk (adjusted odds ratio [OR] = 1.37, 95% CI: 1.06-1.77, P = 0.016; adjusted OR = 2.29, 95% CI: 1.05-5.02, P = 0.038). Immotile sperm percentage also positively correlated with DFI (adjusted OR = 1.04, 95% CI: 1.03-1.05, P < 0.001). CONCLUSION: Elevated sperm DFI did not significantly impact IVF/ICSI outcomes, suggesting limited utility as a routine pretreatment assessment in ART.