Covid‐19 Vaccination and Menstrual Health

项目摘要/摘要 尽管坊间报道盛行，但SARS-CoV-2感染或接种疫苗对月经过多和 月经规律尚未被调查。新冠肺炎病影响数百万人，而他们却呆在家里 订单和不断加剧的压力已经影响了数十亿美元。月经过多、月经不规律和慢性盆腔 众所周知，疼痛(伴有或不伴有子宫内膜异位症)在受到压力挑战时会加重，解体 个人应对机制的缺陷，或获得医疗保健的机会减少--所有这些都发生在COVID期间- 19大流行。要成功评估可归因于以下原因的月经和妇科特征的变化 SARS-CoV-2感染或接种，关键是要比较感染后或接种后的月经和 盆腔症状与接触前月经的关系，并比较这些人的月经 那些已经感染或接种疫苗的人，考虑到大流行的影响可能有所不同 由个人的社会或经济脆弱和心理健康决定。以科学严谨的态度回答这些关键问题 在现有研究中，队列人群对特殊兴趣通知(NOSI)做出反应，以鼓励 行政补充申请以调查新冠肺炎疫苗接种和月经情况(非HD-21- 035)。我们的母公司R01基金专注于哈佛大学队列中的不孕不育和长期健康结果， 主要在护士健康研究II中。虽然NHSII队列的当前年龄范围不适合 专注于月经变化的发现，我们的团队和基础设施还包括来自 2010年开始的护士健康研究3(NHS3；基线年龄为19-51岁)和今天的成长 1996年开始的研究(Guts)(目前年龄24-39岁)。一系列为期一年的新冠肺炎疫情调查 于2020年4月推出。40%(N=11,976)的女性完成了基线新冠肺炎调查 参与者，其中80%的应答者是一线医疗保健提供者，41%(N=4681)的女性 GUTS参与者，其中22%的应答者是一线医疗保健提供者。在这两个当中 协调队列，我们将确认1)SARS-CoV-2感染或2)接种疫苗是否与事件或 与大流行前、感染前或感染前相比，月经过多、月经不规律或盆腔疼痛加重 接种疫苗的月经特征，并与既未感染也未接种疫苗的人进行比较； 以及3)新冠肺炎大流行相关痛苦的增加(如抑郁、焦虑、社会孤立、经济 危险)将与月经过多、月经周期不规律或慢性月经过多的事件或加重有关 盆腔疼痛--不受SARS-CoV-2感染或接种疫苗的影响。当许多人争先恐后地集合 研究小组并建立新的人力数据和样本收集，这将产生不确定的交付成果， 样本量小，通常依赖于完全未识别的样本，以便与之混淆和修改 不能有效评估，建议的研究利用既定的资源，提供成本和 时间效率以及科学上可靠的机会。

PROJECT SUMMARY/ABSTRACT Despite prevalent anecdotal reports, the impact of SARS-CoV-2 infection or vaccination on menorrhagia and menstrual regularity has not been investigated. COVID-19 disease has impacted millions, while stay-at-home orders and heightened stress have impacted billions. Menorrhagia, menstrual irregularity, and chronic pelvic pain (with or without endometriosis) are known to increase in severity when challenged with stress, unraveling of personal coping mechanisms, or diminished access to healthcare – all of which occurred during the COVID- 19 pandemic. To successfully assess changes in menstrual and gynecologic characteristics attributable to SARS-CoV-2 infection or vaccination, it is critical to compare post-infection or post-vaccination menstruation and pelvic symptoms to that person’s pre-exposure menstruation and also to compare menstruation among those who have been infected or vaccinated to those who have not, accounting for pandemic impacts that may vary by individual social or economic frailty and mental health. Answering these critical questions with scientific rigor in existing research cohort populations is responsive to Notice of Special Interest (NOSI) to Encourage Administrative Supplement Applications to Investigate COVID-19 Vaccination and Menstruation (NOT-HD-21- 035). Our Parent R01 funding focuses on infertility and long-term health outcomes within the Harvard Cohorts, primarily within the Nurses’ Health Study II. While the current age range of NHSII cohort does not accommodate menstrual-change focused discovery, our team and infrastructure also include leaders and resources from the Nurses’ Health Study 3 (NHS3; age 19-51 years at baseline) that began in 2010 and the Growing Up Today Study (GUTS) that began in 1996 (current age 24-39 years). A year-long series of COVID-19 pandemic surveys were launched in April 2020. Baseline COVID-19 surveys were completed by 40% (N=11,976) of female NHS3 participants among whom 80% of responders are frontline healthcare providers and 41% (N=4,681) of female GUTS participants among whom 22% of responders are frontline healthcare providers. Within these two harmonized cohorts, we will confirm if 1) SARS-CoV-2 infection or 2) vaccination are associated with incident or worsened menorrhagia, menstrual irregularity or pelvic pain compared to pre-pandemic, pre-infection, or pre- vaccination menstrual characteristics and compared to those who have neither been infected nor vaccinated; and 3) increase in COVID-19 pandemic-related distress (e.g. depression, anxiety, social isolation, economic peril) will be associated with incident or increased severity of menorrhagia, menstrual cycle irregularity, or chronic pelvic pain – independent of SARS-CoV-2 infection or vaccination. While many are scrambling to assemble research teams and establish de novo human data and sample collection, which will yield uncertain deliverables, small samples sizes, and often reliance on fully de-identified samples from which confounding and modification cannot be validly assessed, the proposed study capitalizes on well-established resources providing cost and time efficiency as well as scientifically robust opportunity.