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

描述（由申请人提供）：尽管越来越多地使用增强生育能力的疗法，但对不孕妇女的健康或抗逆转录病毒治疗的特殊效果知之甚少。尽管一些研究表明与ART相关的健康风险，但其他研究指出潜在的不孕症诊断是一个更大的风险因素。除了潜在的低生育能力外，还需要开展研究，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，癌症风险增加）和间接影响（例如，促进大龄母亲或涉及多胎等并发症的母亲怀孕）。该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与预防中心之间的一项创新合作。该合作有助于创建一个独特的纵向关联的、基于人群的数据库，该数据库将有关ART治疗和不孕症诊断的详细临床信息与马萨诸塞州妊娠至早期生命纵向（PELL）数据系统相结合，该系统包含有关怀孕、出生、死亡、医院利用和成本的关联数据，并且作为该项目的一部分，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治疗后长达8年的健康结果：接受ART辅助妊娠的妇女（~25,000），未接受ART但生育能力低下的妇女（~6,000），接受ART但未怀孕超过20周的妇女（~22,000）和分娩时未接受ART或生育能力低下的妇女（~305,000）。该项目解决了先前ART研究的主要局限性：有限的低生育能力比较组和缺乏基于人群的数据和妇女健康的纵向测量。最初将检验两个广泛的假设：(1)通过抗逆转录病毒治疗怀孕的妇女与以下妇女相比，健康结果受损的风险更高：(a)生育能力低下但未接受抗逆转录病毒治疗且怀孕20周的妇女；(b)没有生育能力低下或抗逆转录病毒治疗指标且怀孕20周的妇女；(2)通过抗逆转录病毒治疗怀孕的妇女因抗逆转录病毒治疗参数、不孕症诊断及其相互作用而健康受损的风险不同。另外两项分析将检查重要妇女亚组的健康结果：(a)接受抗逆转录病毒治疗但没有怀孕的妇女；(b)在研究的时间范围内怀孕一次以上的妇女，其中一次涉及抗逆转录病毒治疗，另一次没有。其结果将是迄今为止就不孕不育和抗逆转录病毒治疗对妇女健康的短期、即时和长期影响进行的规模最大、最精细的研究。

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.