A prospective study of male factors, fertility, and pregnancy outcomes

男性因素、生育力和妊娠结局的前瞻性研究

• 批准号: 10677196
• 负责人: MICHAEL L EISENBERG
• 金额: $ 17.75万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-10-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10677196
• 关键词: Address; Affect; Age; American; Behavior; Biotechnology; COVID-19; COVID-19 impact; COVID-19 pandemic; COVID-19 vaccination; Canada; Clinic Visits; Clinical Trials; Collection; Communities; Conceptions; Confidence Intervals; Contraceptive methods; Couples; Data; Data Collection; Data Reporting; Diagnosis; Diet; Dose; Eligibility Determination; Enrollment; Event; Female; Fertility; Financial cost; Funding; Geography; Goals; Health; Health Personnel; Healthcare; Home; Hospitals; Incidence; Individual; Infection; Infrastructure; Interdisciplinary Study; Investigation; Joints; Life Style; Measures; Medical; Medical History; Modeling; North America; Online Systems; Outcome; Participant; Population; Population Heterogeneity; Positioning Attribute; Pregnancy; Pregnancy Outcome; Pregnancy Tests; Pregnancy loss; Process; Prospective Studies; Prospective, cohort study; Public Health; Publications; Publishing; Questionnaires; Race; Registries; Reporting; Research; Risk; Risk Factors; SARS-CoV-2 infection; SARS-CoV-2 infection history; Series; Spontaneous abortion; Testing; Time; United States; United States National Institutes of Health; Vaccinated; Vaccination; Vaccines; Woman; aged; booster vaccine; cohort; coronavirus disease; follow-up; hazard; infertility treatment; male; member; pandemic disease; post SARS-CoV-2 infection; pregnant; prospective; psychologic; recruit; reproductive; reproductive outcome; research study; secondary analysis; sociodemographics; socioeconomics; stressor; subfertility; trying to conceive; vaccine safety

ABSTRACT The proposed supplement will be based on data from Pregnancy Study Online (PRESTO), an ongoing NIH- funded prospective cohort study that enrolls women trying to conceive and follows them from preconception through 6 months after delivery (R01HD086742). Eligible female participants are aged 21-45 years, residents of North America, trying to conceive, and not using contraception or fertility treatment at enrollment. After enrollment, female participants invite their male partners to complete a baseline questionnaire. During 6/2013- 7/2022, PRESTO has enrolled more than 16,750 female participants and nearly 4,000 of their male partners. All questionnaires are completed online and data collection continued during the COVID-19 pandemic. In April 2020, we added new questions for both partners on COVID-19 infection and stressors related to the pandemic, including changes in lifestyle, behaviors and health care, and in January 2021, we added questions for both partners on SARS-CoV-2 vaccination (ever vaccinated, type of vaccine, and date of each shot). In November 2021, we added questions about booster shots. We also obtained female-reported data on male SARS-CoV-2 vaccination and COVID-19 infection data in the event that the male partner did not enroll. Since the study’s inception, participants have reported detailed baseline data about socio-demographics, lifestyle, anthropometrics, and medical history. On each bimonthly questionnaire (administered for up to 12 months), female participants report additional data about their pregnancy status and any changes in their exposures or covariates. We will use the above prospectively-collected data to examine the extent to which SARS-CoV-2 vaccination and COVID-19 infection in both partners are associated with spontaneous abortion (SAB), including early SAB (<8 weeks of gestation). We will consider various windows of possible effects of vaccination and infection, examine the number of vaccine doses (including boosters), and identify differences by other possible effect modifiers (e.g., age). We will control for several confounders, including COVID-19-related stressors, and also present results separately by early and late SAB (<8 vs. ≥8 weeks of gestation). Finally, we will examine the effects of joint exposures in both members of a couple (e.g., both partners vaccinated, female partner vaccinated, male partner vaccinated, vs. neither partner vaccinated). Among at least 1,600 U.S. participants who reported a study-related conception after 12/14/2020, we will estimate the hazard ratio and 95% confidence interval using Cox proportional hazards regression models. Our interdisciplinary research team has published extensively on vaccine-related effects and reproductive outcomes, many of which are based on PRESTO data, and we have the expertise necessary to study these research questions. Given our ongoing prospective data collection throughout the pandemic, our successful recruitment of a large and diverse population of couples, and our prospective collection of pregnancy data, PRESTO is uniquely-positioned to analyze data on vaccination and SAB and provide essential information to the scientific community and the public on vaccine safety.

摘要 拟议的补充将基于妊娠研究在线（PRESTO）的数据，这是一项正在进行的NIH- 一项受资助的前瞻性队列研究，招募了试图怀孕的妇女，并从孕前开始跟踪她们 至分娩后6个月（R 01 HD 086742）。符合资格的女性参与者年龄在21-45岁之间， 北美，试图怀孕，并且在入组时未使用避孕或生育治疗。后 在登记时，女性参与者邀请其男性伴侣完成基线问卷。2013年6月期间- 7/2022，PRESTO已经招募了超过16，750名女性参与者和近4，000名男性伴侣。所有 于COVID-19疫情期间，问卷于网上完成，并继续收集数据。2020年4月， 我们为合作伙伴增加了关于COVID-19感染和与大流行相关的压力因素的新问题， 包括生活方式，行为和医疗保健的变化，并在2021年1月，我们增加了这两个问题 合作伙伴的SARS-CoV-2疫苗接种情况（接种过疫苗、疫苗类型和每次接种的日期）。十一月 2021年，我们增加了关于加强注射的问题。我们还获得了男性SARS-CoV-2的女性报告数据 如果男性伴侣未入组，则提供疫苗接种和COVID-19感染数据。因为这项研究 开始时，参与者报告了有关社会人口统计学，生活方式， 人体测量和病史在每两个月一次的问卷调查中（长达12个月）， 女性受试者报告有关其妊娠状态和暴露量变化的其他数据， 协变量我们将使用上述前瞻性收集的数据来研究SARS-CoV-2 双方接种疫苗和COVID-19感染与自然流产（SAB）相关，包括 早期SAB（<8周妊娠）。我们将考虑疫苗接种可能产生的各种影响， 感染，检查疫苗剂量（包括加强剂）的数量，并确定其他可能的差异 效果调节剂（例如，年龄）。我们将控制几个混杂因素，包括COVID-19相关的压力因素， 还分别按早期和晚期SAB（<8 vs. ≥8孕周）显示结果。最后，我们将研究 在一对夫妇的两个成员中联合暴露的影响（例如，伴侣双方均接种疫苗，女性伴侣 接种疫苗，男性伴侣接种疫苗，与伴侣均未接种疫苗）。在至少1,600名美国参与者中， 在2020年12月14日之后报告了研究相关受孕，我们将估计风险比和95%置信度 使用考克斯比例风险回归模型。我们的跨学科研究团队发表了 广泛研究疫苗相关影响和生殖结果，其中许多是基于PRESTO数据， 我们拥有研究这些研究问题所需的专业知识。根据我们正在进行的前瞻性数据 在整个疫情期间收集，我们成功招募了大量不同的夫妇， 我们前瞻性收集妊娠数据，PRESTO非常适合分析疫苗接种数据 和SAB，并向科学界和公众提供有关疫苗安全性的基本信息。