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临床试验/NCT03650829
NCT03650829招募中不适用

IVF Offspring Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2012年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
1
主要终点
Intelligence quotient of offspring

研究概览

简要总结

The IVF Offspring Born in Guangzhou Cohort Study (IVF-BIG) was established to investigate the short- and long-term effects of exposure in early life on the health of mothers and offspring in Guangzhou, China. Data are collected regarding assisted reproductive technology (ART), environmental, occupational and lifestyle exposures as well as health outcomes in their later life. Biological samples including blood and tissue samples are also collected from participants.

详细描述

It has been 40 years since the first IVF baby born in the world. The effects of hormonal drugs used on women and health of IVF offspring have always been concerned in the reproductive field and in public. With the increase of the prevalence of infertility and development of ART, China is facing a IVF babies boom. It has been reported that ART was associated with higher risk of cancers among women undergoing treatment of ART, and an increased incidence of autism and noncommunicable chronic diseases, such as obesity, among IVF offspring. Epigenetics is documented as one of the possible mechanisms, while answers remain to be explored. A birth cohort would provide an opportunity to examine the short- and long-term effects of ART exposure on health consequences of the mothers and babies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pregnant women with <20 weeks of gestation
  • Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
  • Permanent residents or families intended to remain in Guangzhou with their child for ≥3 years
  • Pregnant women conceived by assited reproductive technology

排除标准

  • 未提供

结局指标

主要结局

Intelligence quotient of offspring

时间窗: At age of 6 years old

Assessed using Wechsler's Intelligence Scale of Children (WISC) including verbal test and performance test.Intelligence quotient ranges from 40 to 160, in which under 70 is defined as mental retardation

次要结局

  • Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect(At delivery)
  • Neurodevelopment at early childhood(At age of 1 year old)
  • Change of intestinal flora during early childhood(At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old)
  • Height changes during early childhood(At birth, age of 6 weeks, 6 months, 1 year and 3 years old)
  • Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section(From 20 weeks of gestation to delivery)
  • Changes of body composition and bone density during early childhood(At age of 3 years,6 years, 12 years and 18 years old)
  • Weight changes during early childhood(At birth, age of 6 weeks, 6 months, 1 year and 3 years old)
  • Epegenetic profiles of offspring(At age of 1 year, 6 years, 12years and 18 years old)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiu Qiu

Director of the Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center

研究点 (1)

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