Determining the impact of COVID-19 vaccination on the menstrual cycle

项目摘要 本母公司奖R 01 HD 089957的补充将使用几个现有的大型美国数据集， 确定COVID-19疫苗对月经健康的影响。虽然父母奖的重点是月经 周期的变化与排卵和肥胖的直接措施作为主要的曝光，这种补充将重点 关于COVID-19疫苗作为主要暴露、月经周期变化和排卵的间接措施。 我们将利用类似的科学方法批准的具体目标1和2的母奖，包括 使用有效的测量方法对月经周期进行前瞻性跟踪， 不同体重指数的女性，月经周期规律，未使用激素避孕药。 公众越来越关注COVID-19与月经健康之间可能存在的联系。这 担忧可能导致个人及其家庭对疫苗接种犹豫不决;对实现足够的接种率构成威胁 疫苗接种和使更多的致命变种的发展的机会窗口。 月经周期是健康和生育能力的明显标志。因此，我们有能力更好地了解 COVID-19疫苗和月经健康之间是否存在关联， 这些人的身体和精神健康，他们的社区，以及我们更大的公共卫生。 此补充“COVID-19疫苗接种和月经”的目标是确定COVID-19是否 接种疫苗会引起月经失调。我们的主要结果是女性内的平均差异 接种疫苗前后或未接种疫苗前后的月经周期长度（天）以及次要结局 与月经周期时间和疫苗反应的严重程度以及月经特征的变化有关 (e.g.流量、长度、疼痛、相关症状、经间期出血）。我们将进行一次回顾 使用COVID-19前后经验证的测量方法分析前瞻性跟踪的月经周期数据 接种疫苗或未接种疫苗组的时间相似。我们将开发多变量物流 回归模型考虑了所有可用的潜在混杂因素，包括但不限于疫苗类型，BMI， 年龄，种族/民族，生活压力等。我们的团队已经收到了两个领先的在线月经的承诺， 具有内置用户批准的周期跟踪平台，以提供这种去识别数据用于研究目的 加上调查这些用户以获得附加数据的能力。截至2021年6月，他们报告了累计 具有“自然”周期（无激素避孕）的活跃美国育龄使用者数量约为 两百万

Project Summary This supplement to the parent award R01HD089957 will use several large preexisting US-based datasets to determine the impact of COVID-19 vaccine on menstrual health. While the parent award focuses on menstrual cycle changes with direct measures of ovulation and obesity as the main exposure, this supplement will focus on the COVID-19 vaccine as the main exposure, menstrual cycle changes, and indirect measures of ovulation. We will utilize similar scientific methods approved of in Specific Aims 1 and 2 of the parent award including prospective tracking of the menstrual cycle using validated measures and the inclusion of reproductive-age women of varying body mass index with regular menstrual cycles not using hormonal contraception. Public concern is mounting regarding the possible association between COVID-19 and menstrual health. This concern could lead to vaccine hesitancy for individuals and their families; a threat to achieving sufficient rates of vaccination and enabling windows of opportunity for the development of additional virulent variants. Menstrual cyclicity is an overt sign of health and fertility. Thus, our ability to gain a greater understanding of whether or not an association exists between COVID-19 vaccine and menstrual health is critical for the physical and mental well-being of those who menstruate, their community, and our greater public health. The goal of this supplement “COVID19 vaccination and Menstruation” is to determine if COVID-19 vaccination causes menstrual disturbances. Our primary outcome is the within-woman difference in mean menstrual cycle length (in days) pre- and post-vaccination or unvaccinated as well as secondary outcomes related to menstrual cycle timing and severity of vaccine response and changes in menstrual characteristics (e.g. flow, length, pain, associated symptoms, intermenstrual bleeding). We will perform a retrospective analysis of prospectively tracked menstrual cycle data utilizing validated measures pre- and post-COVID-19 vaccination or over similar time period for the unvaccinated group. We will develop a multi-variable logistic regression model considering all available potential confounders including but not limited to vaccine type, BMI, age, race/ethnicity, life stressors, etc. Our team has received the commitment of two leading online menstrual cycle tracking platforms with the built-in user approval to provide this de-identified data for research purposes plus the ability to survey these users to obtain additional data. As of June 2021, they report a cumulative number of active US reproductive age users with ‘natural’ cycles (no hormonal contraception) of approximately 2 million.