Infertility Treatment, Child Growth and Development Through Age Three Years

这项研究于2007年9月4日开始，旨在使用基于人群的抽样策略招募和比较婴儿匹配暴露队列的发展，即，在出生证明上注明的在不孕症治疗的帮助下怀孕的婴儿，以及在没有这种治疗的情况下怀孕的婴儿。 这是可能的，因为修订后的美国活产标准证书正在全国范围内分阶段实施，其中包括关于在产前检查和程序部分使用不孕症治疗的问题，并且一些州已经实施了类似的州特定复选框或修订后的美国出生证明。 对于主要队列，共有1，500名出生证明上确定为通过不孕症治疗（暴露）受孕的婴儿在3-5个月时入组为受试者（如有必要，进行妊娠校正）并纵向随访至36个月（3岁），沿着4，500名未暴露婴儿的队列，与母亲年龄、居住地邮政编码、和出生的多样性。 研究受试者的所有双胞胎应同时入组，并记录其结局（例如，死产、新生儿死亡），或者按照与研究参与者相同的时间表对其进行随访（第二队列），尽管双胞胎不被视为主要队列的一部分。 无论暴露状态如何，所有更高阶倍数（三胞胎、四胞胎）也将入组并按照相同的时间表进行随访。 假设不孕症治疗的出生结果中约有三分之一是双胞胎或更高倍数的婴儿，预计第二队列的人数约为2，000人（500名暴露婴儿的双胞胎兄弟姐妹和1，500名未暴露婴儿的双胞胎兄弟姐妹）加上所有更高倍数的婴儿。 所有婴儿都有资格被挑选，不分种族、民族或性别。 参考（主要）出生队列的招募期预计将持续10个月至一个日历年。 研究的抽样范围是纽约州，不包括纽约市。 在纽约州出生的婴儿的父母将被要求参加为期三年的研究：（a）完成关于怀孕的初始问卷，包括例如不孕症治疗的确认、怀孕时间、婴儿喂养和其他人口统计学和社会经济因素（即，母亲教育、职业）以及与运动和社会发展相关的混杂因素;（B.）完成标准化筛查工具，其解决他们的查尔兹孩子在按时间顺序或经妊娠校正的年龄4、8、12、16、20、24、30和36个月时的运动和社会发育;以及（c.）提供关于儿童查尔兹生长和病史的信息（例如，疾病、出生缺陷诊断、重大损伤）。 关于生长和病史的信息将以期刊的形式从医生的检查数据中收集。 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）。

This 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 on birth certificates, and infants who were conceived without such therapies. This is possible because the revised U.S. Standard Certificate of Live Birth that is being phased in nationally includes a question about the use of infertility treatment in the prenatal tests and procedures section, and some States have already implemented either a comparable State-specific check box or the revised U.S. Birth Certificate. For the primary cohort, a total of 1,500 infants identified on birth certificates as having been conceived by infertility treatment (exposed) are to be 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 of 4,500 unexposed infants, frequency-matched for maternal age, zip code of residence, and plurality of birth. All co-twins of Study participants are to be enrolled simultaneously and either their outcomes noted (e.g., stillbirth, neonatal mortality), or they are to be followed (secondary cohort) on the same schedule as Study participants, although the co-twins will not be considered as part of the primary cohort. All higher order multiples (triplets, quadruplets) are also to be enrolled and followed on the same schedule, regardless of exposure status. Assuming that approximately a third of the birth outcomes from infertility treatment are twins or higher order multiples, the secondary cohort is expected to number about 2,000 (500 twin siblings of exposed and 1,500 twin siblings of unexposed infants) plus all higher order multiples. All infants are eligible for selection without regard to race, ethnicity or gender. The period of recruitment for the referent (primary) birth cohort is expected to last 10 months to one calendar year. The sampling frame for the Study is New York State (NYS), exclusive of New York City. Parents of infants born in NYS will be 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 childs growth and medical history (e.g., illnesses, diagnoses of birth defects, major impairments). Information on growth and medical history will be 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).