Infertility Treatment, Child Growth and Development Through Age Three Years

这项研究的抽样范围是纽约州(NYS)，不包括纽约市。这项研究始于2007年9月4日，旨在使用基于人群的抽样策略来招募和比较匹配暴露婴儿队列的发育情况，即根据纽约围产期数据系统的记录，通过不孕症治疗怀孕的婴儿，以及没有接受这种治疗的婴儿。不孕症治疗暴露是抽样的基础，因为其相对稀有。对于初级队列，被确认为通过不孕症治疗(暴露)受孕的婴儿在3-5个月大时被登记为参与者(如有必要，经妊娠校正)，并进行纵向跟踪，直到36个月(3岁)，以及一组未暴露于不孕症的婴儿，这些婴儿与居住在NYS区域围产期网络中并多次生育的婴儿频率匹配。研究参与者的所有同卵双胞胎都是同时登记的，要么他们的结果被记录下来(例如，死产、新生儿死亡率)，要么他们与研究参与者按照相同的时间表被跟踪(第二队列)，尽管同卵双胞胎将不被视为主要队列的一部分。更高阶的倍数(三胞胎、四胞胎)也被登记，并遵循相同的时间表，无论暴露状态如何。招募窗口从2008年9月17日(第一次邮寄)延长到2010年12月17日(收到最终同意)，大约为两年的出生时间。招募目标受到密切监测，因此最终招募的初级队列样本是1,297名暴露在不孕症治疗中的母亲和婴儿，以及3,692名未暴露在不孕症治疗中的母亲和婴儿，其中双胞胎约占每个队列的22%。招募了45组高阶胎(43个三胞胎，2个四胞胎)，总共有5,034个母婴(S)。 在纽约出生的婴儿的父母被要求参加这项为期三年的研究：(A)填写关于怀孕的初步问卷，包括确认不孕症治疗、怀孕时间、婴儿喂养以及其他人口和社会经济因素(即产妇教育、职业)以及与运动和社会发展有关的混杂因素；(B)完成标准化筛查工具，了解儿童在4、8、12、16、20、24、30和36个月时的运动和社会发育情况；(C)提供有关儿童成长和病史的信息(例如，疾病、出生缺陷诊断、重大损伤)。关于成长和病史的信息以日记的形式从医生检查数据中汇编而来。记录将链接到其他相关的健康记录(例如，早期干预计划、WIC、出生缺陷或癌症登记)。 增加了几个额外的组成部分：(A)(B)与辅助生殖技术学会(SART)基于周期的数据库链接，提供详细的艺术史；获取强制性新生儿筛查和实验室生物标记物和环境暴露测试遗留下来的血样。血液样本由沃兹沃斯中心实验室(纽约州卫生局)拥有并存档，以及(C)计划使用一系列经过经验验证的可靠工具，对所有未通过任何神经发育筛查的婴儿和儿童进行标准化评估，以诊断36个月大的发育障碍。

The sampling frame for the Study is New York State (NYS), exclusive of New York City. The Study, which began September 4, 2007, is designed to use a population-based sampling strategy to recruit and compare the development of a matched-exposure cohort of infants, i.e., infants identified from pregnancies conceived with the help of infertility treatment, as noted in the NYS Perinatal Data System, and infants who were conceived without such therapies. The infertility treatment exposure is the basis for the sampling because of its relative rarity. For the primary cohort, infants identified as having been conceived by infertility treatment (exposed) were enrolled as participants at 3-5 months of age (gestation-corrected, if necessary) and followed longitudinally until age 36 months (3 years), along with a cohort unexposed infants, frequency-matched for residence within a NYS Regional Perinatal Network and plurality of birth. All co-twins of Study participants were enrolled simultaneously and either their outcomes noted (e.g., stillbirth, neonatal mortality) or they are being followed (secondary cohort) on the same schedule as Study participants, although the co-twins will not be considered as part of the primary cohort. Higher order multiples (triplets, quadruplets) were also enrolled and followed on the same schedule, regardless of exposure status. The recruitment window extended from September 17, 2008 (first mailing) through December 17, 2010 (final consent received), representing an approximate 2-year period of births. Recruitment goals were closely monitored so that the final recruited primary cohort sample was 1,297 exposed (infertility treatment) and 3,692 unexposed (no infertility treatment) mothers and infants, with twins making up about 22% of each cohort. There are 45 sets of higher order multiples (43 triplet, 2 quadruplets) recruited, such that there is a total of 5,034 mother/infant(s) sets. Parents of infants born in NYS are asked to participate in the Study for three years by: (a.) completing an initial questionnaire about the pregnancy, including, for example, confirmation of infertility treatment, time-to-pregnancy, infant feeding, and other demographic and socioeconomic factors (i.e., maternal education, occupation) and confounders associated with motor and social development; (b.) completing a standardized screening instrument that addresses their childs motor and social development at chronologic or gestation-corrected ages 4, 8, 12, 16, 20, 24, 30, and 36 months; and (c.) providing information on the child's growth and medical history (e.g., illnesses, diagnoses of birth defects, major impairments). Information on growth and medical history are assembled in journal format from physicians examination data. Records will be linked to other pertinent health records (e.g., early intervention programs, WIC, birth defect or cancer registries). Several additional components have been added: (a.) a detailed ART history by linking with the Society for Assisted Reproductive Technology (SART) cycle-based database; (b.) the acquisition of residual blood specimens left over from mandatory neonatal screening and laboratory testing for biomarkers and environmental exposures. The blood specimens are owned and archived at the Wadsworth Center Laboratories (New York State Department of Health), and (c.) plans for the administration of a standardized assessment for diagnosing developmental disabilities using a battery of empirically validated and reliable instruments around 36 months of age for all infants and children who fail any of the neurodevelopmental screens.