DataSheet_1_Optimal Follow-Up Duration for Assessment of Birth Defects After In Vitro Fertilization–Embryo Transfer: A Multicenter 5-Year Cohort Study in China.pdf

ObjectiveTo investigate the impact of a 5-year follow-up on the incidence of identified birth defects in children conceived using assisted reproductive technologies (ART).MethodsA 5-year cohort study was performed in three ART centers from January 2013 to October 2018. 1,543 women with 1,985 infants who delivered successfully or underwent termination of pregnancy due to malformations were recruited in this study. Follow-up was conducted by phone interview, 7 days, 1 year, 3 years, and 5 years after birth. Collected data included whether one or more birth defects were diagnosed, the category of birth defects, and when the malformation was diagnosed. Cumulative incidence of birth defects and the loss to follow-up rate of each follow-up was compared.ResultsAccording to the diagnostic criterion of birth defects, 111 cases of one or more birth defects were recorded, with a total of 117 birth defects after the 5-year follow-up. 0.2% (4/1,985) of birth defects were diagnosed before delivery; 2.7% (54/1,985) at 7 days; 5.0% (100/1,985) after 1 year; 5.5% (109/1,985) after 3 years; and 5.6% (111/1,985) after 5 years. 3.4% (4/117) of defects were diagnosed prenatally, 45.3% (53/117) of defects diagnosed within the first 7 days after delivery, 40.2% (47/117) diagnosed during 7 days to 1 year, and 9.4% (11/117) of defects diagnosed in 1–3 years after birth. The remaining 1.7% (2/117) of defects were diagnosed between the ages of 3 and 5 years. Among the 1,543 patients, 99.9% patients (1,542/1,543) responded to the telephone interview at 7 days after delivery; the response rate was 89.0% (1,373/1,543) at 1 year, 81% (1,250/1,543) at 3 years, and 64.5% (995/1,543) after 5 years.ConclusionWe suggest that in ART, 1-year follow-up should be the minimum requirement and 3-year follow up the optimal length of follow-up that balances resource requirements with ascertainment completeness.

研究目的：探究对辅助生殖技术（ART）受孕儿童出生缺陷发生率的五年随访影响。研究方法：自2013年1月至2018年10月，在三个ART中心开展了一项为期五年的队列研究。本研究招募了1,543名成功分娩或因畸形终止妊娠的妇女及其1,985名婴儿。随访通过电话访谈进行，包括出生后第7天、1年、3年和5年。收集的数据包括是否诊断出一种或多种出生缺陷、出生缺陷的分类以及畸形的诊断时间。比较了出生缺陷的累积发生率以及每次随访的失访率。研究结果：根据出生缺陷的诊断标准，记录了111例一种或多种出生缺陷，五年随访后共计117例出生缺陷。0.2%（4/1,985）的出生缺陷在分娩前被诊断；2.7%（54/1,985）在出生后第7天；5.0%（100/1,985）在1年后；5.5%（109/1,985）在3年后；5.6%（111/1,985）在5年后。3.4%（4/117）的缺陷在产前诊断，45.3%（53/117）的缺陷在分娩后第1周内诊断，40.2%（47/117）在分娩后第7天至1年内诊断，9.4%（11/117）的缺陷在出生后1至3年内诊断。剩余的1.7%（2/117）的缺陷在3至5岁之间诊断。在1,543名患者中，99.9%的患者（1,542/1,543）在分娩后第7天接受了电话访谈；1年后的响应率为89.0%（1,373/1,543），3年为81%（1,250/1,543），5年后为64.5%（995/1,543）。研究结论：我们建议在ART中，一年的随访应为最低要求，而三年的随访则为平衡资源需求与确诊完整性的最佳时长。