Abstract

Abstract Study question To analyse the effect of COVID-19 vaccines on sperm parameters in Indian men seeking infertility treatment. Summary answer COVID-19 vaccination did not impact the sperm parameters of Indian men undergoing infertility treatment in this study. What is known already The COVID-19 pandemic triggered an expedited response from the scientific community to develop preventive vaccine programs against the deadly SARS-CoV-2 virus. Although COVID-19 is predominantly a respiratory system illness, initial reports suggested that it could have a short-term negative impact on the sperm parameters of the males affected by the disease too. Misinformation led to unfounded concerns about the potential consequences of the vaccines on male fertility, causing a great deal of initial vaccine hesitancy. To address these concerns, we compared the sperm parameters in men before and after COVID vaccination available in India at the time of this study. Study design, size, duration It was a multi-centre, prospective, observational study of 960 male participants conducted at our fertility clinics between June 2021 to December 2022. The study participants were matched for age and had no known risk factors. We excluded 267 participants from this study since they did not meet the inclusion criteria, bringing our total study population down to 693. Participants/materials, setting, methods The study participants provided two semen samples for analysis before and after receiving any of the COVID-19 vaccines available in India at the time of this study. A trained embryologist analysed the pre-vaccination and post-vaccination sperm concentration and motility of these males, following the 6th Edition of WHO Manual for Semen Analysis. GraphPad Prism 9 was used for statistical analysis of the data & p ≤ 0.05 was considered statistically significant. Main results and the role of chance The study enrolled 693 people, with 96.5% receiving at least one dose and 90.35% receiving two or more. The most common vaccines used among the group were Indian made-Covishield and Covaxin, received by 71.8% & 24.3% of the participants, respectively. In the group of participants who had tested positive for COVID (n = 259), the sperm concentration increased by 3.29 million/ml and the total motility increased by 3.24% post-vaccination. However, these changes were not statistically significant (p = 0.140 and p = 0.099, respectively). In the group of participants who had not tested positive for COVID (n = 424), we observed a similar increase in sperm concentration and total motility post-vaccination. The sperm concentration increased by 1.52 million/ml and the total motility increased by 0.85%. However, these changes were also not statistically significant (p = 0.580 and p = 0.404, respectively). Subgroup analysis of different vaccines did not reveal any statistically significant differences either. In conclusion, the study found that COVID-19 vaccination, including the type of vaccine used, did not significantly impact sperm parameters in men. Limitations, reasons for caution Supply chain disruptions in the COVID vaccination program meant we could not match the duration between the pre-vaccination and the post-vaccination semen analyses in this study. Additionally, the findings are specific to our study population and may not be generalizable to other populations or settings. Wider implications of the findings This study found that COVID-19 vaccination did not affect the chances of Indian men at fatherhood. Our work also supports the safety of Indian-made vaccines for men seeking infertility treatment, as it is one of the most extensive studies in this area. Trial registration number Not Applicable

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