Background: Coronavirus disease 2019 is a serious global pandemic resulting in rising morbidities and mortalities. Global vaccination programs, using rapidly developed vaccines, resulted in widespread controversy regarding whether they may negatively impact the ovarian reserve, due to a lack of rigorous clinical trials.
Objective: To evaluate the effect of the mRNA Pfizer-BioNTech Covid-19 on anti-mullerian hormone (AMH) and antral follicle count (AFC).
Study Design: A prospective study, consisting of 115 eligible women with normal ovarian reserve, conducted from May to December 2021, at Cairo University. The women were vaccinated by two Pfizer-BioNTech Covid-19 vaccines (21 days apart). Baseline and three-month post vaccine blood samples and pelvic ultraound, were taken to determine AMH and AFC. Primary outcome was defined as the absolute and percentage change in AMH and AFC levels. A decrease of 10% or more in the serum level of AMH or AFC was considered clinically significant.
Results: A significant difference was found between baseline and three-month post vaccination AMH and AFC levels for the whole study group. The proportion of women with a greater than 10% decrease in levels of AMH and AFC following vaccination were less than those with a less than 10% decrease, in the total cohort of women, and within the sub analyses performed for three age groups: <30, 30-35 and >35 years. No significant association between adjusted risk factors (age, BMI and baseline AMH or AFC values) and percentage change of AMH or AFC.
Conclusion: The mRNA SARS–CoV–2 Pfizer/BioNTech vaccine, is not associated with a clinically important change in ovarian reserve. These findings may reassure women hesitant to take the vaccine. Further studies with large sample sizes and with longer follow up periods are needed to ensure the safety of these vaccines.