Women's Health After Assisted Reproductive Technology: A Population-Based Study

描述(申请人提供)：尽管提高生育能力疗法的使用越来越多，但人们对不孕不育妇女的健康状况或ART治疗的特殊效果知之甚少。尽管一些研究表明与抗逆转录病毒治疗相关的健康风险，但另一些研究指出，潜在的不孕不育诊断是一个更大的风险因素。需要进行研究，以确定与抗逆转录病毒疗法相关的风险，区分抗逆转录病毒疗法的潜在直接影响(例如，更大的癌症风险)和抗逆转录病毒疗法的间接影响(例如，促进老年母亲的怀孕或涉及多胞胎等并发症的影响)。这项提案描述了波士顿大学公共卫生学院、马萨诸塞州公共卫生部、辅助生殖技术协会和疾病控制和预防中心之间的创新合作。这项合作有助于创建一个独特的纵向链接的、基于人群的数据库，该数据库将有关ART治疗和不孕不育诊断的详细临床信息与马萨诸塞州怀孕到早期生命纵向(PELL)数据系统相结合，该系统包含有关怀孕、出生、死亡、医院利用和费用的关联数据，作为该项目的一部分，该数据库将添加来自马萨诸塞州癌症登记处的数据。由此产生的数据库将跟踪四组妇女在治疗后长达8年的健康结果：接受抗逆转录病毒治疗的怀孕妇女(约25,000人)，未接受抗逆转录病毒治疗但有亚生育指标的妇女(约6,000人)，接受抗逆转录病毒治疗但未怀孕超过20周的妇女(约22,000人)，以及没有接受抗逆转录病毒治疗或亚生育指标分娩的妇女(约305,000人)。该项目解决了现有技术研究的主要局限性：亚生育率比较群体有限，缺乏以人口为基础的数据和妇女健康的纵向衡量。首先将检验两个广泛的假设：(1)通过抗逆转录病毒疗法怀孕的妇女与以下妇女相比，健康结果受损的风险更高：(A)有亚生育指标但没有抗逆转录病毒疗法的妇女和怀孕20周的妇女；(B)没有亚生育或抗逆转录病毒治疗指标的妇女和怀孕20周的妇女；(2)通过抗逆转录病毒疗法怀孕的妇女，其健康受损的风险因抗逆转录病毒治疗参数、不孕症诊断及其相互作用而不同。另外两项分析将审查重要的妇女亚组的健康结果：(A)患有抗逆转录病毒治疗但没有怀孕的妇女，以及(B)在研究的时间范围内怀孕不止一次的妇女，其中一人涉及抗逆转录病毒治疗，另一人没有。其结果将是有史以来规模最大、最精细的关于不孕不育和抗逆转录病毒疗法对女性健康的短期、即时和长期影响的研究。 公共卫生相关性：研究表明，接受辅助生殖技术(ART)治疗的妇女出现不良健康结果的风险更大，但先前的研究尚未确定这种增加的健康风险在多大程度上与ART治疗、潜在的不孕症诊断或它们的组合有关。拟议的项目将把2004年至2012年的SART CORS临床数据与马萨诸塞州怀孕与早产的纵向出生、胎儿死亡和住院数据文件以及马萨诸塞州癌症登记处联系起来，以开展规模最大的研究(超过45,000名患有ART的妇女；6,000名有亚生育指标但没有接受ART的妇女；以及305,000名怀孕但没有接受ART的妇女)，以及迄今为止最全面的美国研究，考察不孕症和ART对妇女健康的短期、中期和长期(长达8年)的影响。这项研究将检查有亚生育指标的接受ART的妇女与没有接受ART或没有亚生育指标的妇女、接受不同ART治疗和不孕不育诊断的妇女以及接受ART但未怀孕或怀孕少于20周的妇女的健康结果。

DESCRIPTION (provided by applicant): Despite the growing use of fertility-enhancing therapies, little is known about the health of women with infertility, or the particular effects of ART treatments. Although some studies suggest health risks associated with ART, others point to the underlying infertility diagnosis as a greater risk factor. Research is needed to identify risks associated with ART, beyond underlying subfertility, distinguishing potential direct effects of ART (e.g. greater risk of cancer) from indirect effects of ART (e.g., facilitating pregnancies among older mothers or those involving complications such as multiple births). This proposal describes an innovative collaboration between Boston University School of Public Health, the Massachusetts Department of Public Health, the Society for Assisted Reproductive Technology, and the Centers for Disease Control and Prevention. The collaboration facilitates the creation of a unique longitudinally linked, population-based database that combines detailed clinical information on ART treatment and infertility diagnoses with the Massachusetts Pregnancy to Early Life Longitudinal (PELL) Data System, which contains linked data on pregnancy, births, deaths, hospital utilization and costs, and as part of this project, will add data from the Massachusetts Cancer Registry. The resulting database will track health outcomes for women up to 8 years after treatment across four groups: women with pregnancies assisted by ART (~25,000), women without ART but subfertility indicators (~6,000), women with ART and no pregnancy beyond 20 weeks (~22,000) and women who give birth without ART or subfertility indicators (~305,000). This project addresses key limitations of prior ART research: limited subfertility comparison groups and a lack of population-based data and longitudinal measures of health for women. Two broad hypotheses will initially be tested: (1) Women whose pregnancies were conceived through ART have a higher risk of compromised health outcomes compared to: (a) women with indicators of subfertility but no ART and pregnancies of 20 weeks; and (b) women without indicators of subfertility or ART and pregnancies of 20 weeks; and (2) Women whose pregnancies were conceived through ART differ in their risks for compromised health by ART treatment parameters, infertility diagnoses and their interactions. Two additional analyses will examine health outcomes among important subgroups of women: (a) those with ART and no resulting pregnancy and (b) those with more than one pregnancy in the time frame studied, one of which involved ART and one which did not. The result will be the largest, most refined study ever undertaken on the short, immediate and long term effects of infertility and ART on the health of women. PUBLIC HEALTH RELEVANCE: Research has shown that women treated with assisted reproductive technology (ART) are at greater risk for adverse health outcomes, but prior studies have not determined how much of this increased health risk is related to ART treatment, the underlying infertility diagnosis, or their combination. The proposed project will link SART CORS clinical data from 2004 through 2012 to the Massachusetts Pregnancy to Early Life Longitudinal birth, fetal death and hospitalization data files as well as the Massachusetts Cancer Registry to develop the largest (more than 45,000 women with ART; 6,000 women with subfertility indicators and no ART; and 305,000 women with a pregnancy and no ART) and most comprehensive US study to date examining the short, intermediate and long term (up to 8 years) impact of infertility and ART on the health of women. The study will examine health outcomes among women with subfertility indicators who undergo ART compared to those without ART or no subfertility indicators; among women with different ART treatments and infertility diagnoses; and among women who receive ART but do not conceive or have a pregnancy lasting less than 20 weeks.