The high-DNA stainability (HDS) might be an indicator for the detection of sperm chromatin decondensation structure resulting from the incomplete histone-to-protamine exchange. The aim of our study was to investigate the association of HDS with embryonic development and clinical outcomes after in vitro fertilization (IVF) treatment. Couples underwent IVF cycles from January 2016 to December 2020 were retrospectively studied, including a total of 2,604 target couples undergoing IVF treatment and 628 couples undergoing fresh IVF-embryo transplantation (IVF-ET) treatment. Couples were divided into HDS > 15% group and HDS ≤ 15% group according to HDS levels. After controlling the bias between groups using the propensity score-matching method, data of embryonic development, and clinical outcomes were analyzed. No significant differences were observed between HDS > 15% group and HDS ≤ 15% group regarding fertilization rate (83.33% vs. 84.62%,P=0.349), two pronuclei rate (81.82% vs. 83.33%,P=0.613), cleavage rate (100.00% vs. 100.00%,P=0.172), and high-quality embryo rate (60.00% vs. 60.00%,P=0.961). Linear regression analysis showed that HDS was negatively associated with fertilization rate (B value = −0.094, 95% CI: −0.184 to −0.005,P=0.039), whereas no correlation (adjusted B value = −0.081, 95% CI: −0.170 to 0.008,P=0.074) was observed after adjusting potential confounding factors. The clinical pregnancy rate (62.11% vs. 60.39%,P=0.699), ongoing pregnancy rate (52.17% vs. 53.10%,P=0.838), early miscarriage rate (9.94% vs. 7.28%,P=0.283), late miscarriage rate (0.62% vs. 2.14%,P=0.305), and live birth rate (51.55% vs. 50.96%,P=0.838) were not significantly different between groups. Binary logistic regression analysis showed that HDS levels did not affect clinical outcomes after fresh IVF-ET treatments. HDS was not significantly associated with embryonic development and clinical outcomes of IVF. Our findings suggested that HDS evaluation before IVF treatment might be with limited potential to predict embryo development and clinical outcomes.
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