Infertility Treatment, Child Growth and Development Through Age Three Years

这项研究始于2007年9月4日，旨在采用基于人群的抽样策略来招募和比较匹配暴露队列婴儿的发展，即在出生证明上注明的孕产期接受不孕治疗的婴儿和未接受此类治疗的婴儿。这是可能的，因为修订后的美国标准活产证明正在全国分阶段实施，在产前检查和程序部分包括一个关于使用不孕症治疗的问题，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。在主要队列中，共有1500名在出生证明上被确定为通过不孕症治疗（暴露）受孕的婴儿在3-5个月大时（必要时进行妊娠纠正）被纳入参与者，并纵向随访至36个月（3岁），同时还有4500名未暴露的婴儿，与母亲年龄、居住邮政编码和出生次数相匹配。研究参与者的所有双胞胎将同时入组，记录他们的结局（如死产、新生儿死亡率），或者按照与研究参与者相同的时间表对他们进行随访（次要队列），尽管双胞胎将不被视为主要队列的一部分。所有高阶倍数（三胞胎、四胞胎）也将按照相同的时间表进行登记和随访，无论暴露状态如何。假设大约三分之一的不孕症治疗的出生结果是双胞胎或高倍数，第二队列预计将有大约2000人（500名暴露婴儿的双胞胎兄弟姐妹和1500名未暴露婴儿的双胞胎兄弟姐妹）加上所有高倍数。不论种族、民族或性别，所有婴儿都有资格被选择。有关（初级）出生队列的征聘期预计将持续10个月至一个日历年。本研究的抽样框架是纽约州（NYS），不包括纽约市。

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).