The Safety and Efficacy of Inactivated COVID-19 Vaccination in Couples Undergoing Assisted Reproductive Technology: A Prospective Cohort Study

BACKGROUND:The safety of the COVID-19 inactivated vaccine on pregnancy outcomes in couples undergoing assisted reproductive technology remains uncertain due to limited and speculative evidence. Existing studies primarily focus on the vaccination status of females, with scant information available regarding the vaccination status of male partners. Moreover, there is minimal research tracking live birth outcomes. OBJECTIVE(S):The objective of this study was to evaluate the impact of COVID-19 inactivated vaccine administration on the outcomes of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles in infertile couples in China. METHODS:This prospective cohort study involved couples undergoing IVF treatment at Sichuan Jinxin Xinan Women & Children's Hospital from August 2021 to September 2022. Based on whether they received vaccination before ovarian stimulation, the couples were divided into the vaccination group and the non-vaccination group. We compared the laboratory parameters and pregnancy outcomes between the two groups. RESULTS:After performing propensity score matching (PSM), we observed similar live birth rates (41.23% vs. 44.08%, P = 0.555), clinical pregnancy rates (52.61% vs. 54.98%, P = 0.625), biochemical pregnancy (62.56% vs. 63.98%, P = 0.762), and ongoing pregnancy rates (49.76% vs. 51.18%, P = 0.770) between the vaccinated and unvaccinated women. Also, no significant disparities were found in terms of embryo development and laboratory parameters between the groups. Moreover, male vaccination had no impact on patients' pregnancy outcomes in assisted reproductive technology (ART) treatments (all P > 0.05). Additionally, there were no observable effects of vaccination on embryo development and pregnancy outcomes among couples undergoing ART (all P > 0.05). CONCLUSION(S):The findings suggest that COVID-19 vaccination did not have a significant effect on patients undergoing IVF/ICSI with fresh embryo transfer. Therefore, it is recommended that couples should receive COVID-19 vaccination as scheduled to help mitigate the COVID-19 pandemic.