To investigate the effects of hepatitis B virus (HBV) infection on the outcomes of Chinese couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) and the clinical data of their neonates. A total of 21,999 first embryo transfer cycles were included. They were categorized into four groups based on the couple's hepatitis B surface antigen (HBsAg) result (Group A = female HBsAg and male HBsAg ; Group B = female HBsAg and male HBsAg ; Group C = female HBsAg and male HBsAg ; Group D = female HBsAg and male HBsAg ). The fertilization rate (FR), cleavage rate (CR), implantation rate (IPR), clinical pregnancy rate (CPR), live birth rate (LBR) and miscarriage rate (MCR) were analysed. Multilevel logistic regression was applied to evaluate the association. The total prevalence of HBV infection was 5.74% (2526/43998). There were no statistically significant differences in CRs (98.69%, 98.76%, 98.66%, 98.72%, p > .05), IPRs (45.86%, 47.33%, 45.19%, 39.61%, p > .05), CPRs (62.84%, 65.05%, 61.80%, 56.81%, p > .05), MCRs (12.70%, 11.99%, 12.58%, 4%, p > .05) and LBRs (53.43%, 55.38%, 52.70%, 54.54%, p > .05) among the four groups. However, there were significant differences in FRs (66.25%, 66.55%, 66.32%, 61.92%, p < .05). Group D had the lowest FR. After adjusting for confounders, the multilevel logistic regression showed that HBsAg had no impact on the LBR, CPR or MCR. We also analysed the data of 14,465 newborns, including 8593 singletons and 2936 twins. Among the four groups, no variables reached statistical significance, including neonatal birth weight (NBW), twin ratio, gestational age, premature birth, delivery type, fetal macrosomia or low birth weight (p > .05). Our study demonstrates that, although biparental HBV infection may affect the FR, neither single-parent infection nor biparental HBV infection affects IVF/ICSI outcomes or neonatal outcomes.

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