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Clinical Trials/NCT03650829
NCT03650829
Recruiting
Not Applicable

IVF Offspring Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center1 site in 1 country3,000 target enrollmentFebruary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ART
Sponsor
Guangzhou Women and Children's Medical Center
Enrollment
3000
Locations
1
Primary Endpoint
Intelligence quotient of offspring
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2012
End Date
December 31, 2038
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Guangzhou Women and Children's Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Xiu Qiu

Director of the Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Intelligence quotient of offspring

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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