IVF Offspring Born in Guangzhou
- Conditions
- NeurodevelopmentARTGeneticsHost and MicrobiomeOffspring, Adult
- Registration Number
- NCT03650829
- Lead Sponsor
- Guangzhou Women and Children's Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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
• None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intelligence quotient of offspring 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 Outcome Measures
Name Time Method Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect At delivery Assesed by electronic records
Neurodevelopment at early childhood At age of 1 year old Assessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function
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 Assessed by analyses of stool samples
Height changes during early childhood At birth, age of 6 weeks, 6 months, 1 year and 3 years old Height changes from birth, to 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 Assessed by self-reported time of onset and electronic medical records
Changes of body composition and bone density during early childhood At age of 3 years,6 years, 12 years and 18 years old Assessed using Dual Energy X-Ray Absorptiometry
Epegenetic profiles of offspring At age of 1 year, 6 years, 12years and 18 years old Profiling DNA methylation and histone acetylation etc., using blood samples
Weight changes during early childhood At birth, age of 6 weeks, 6 months, 1 year and 3 years old Weight changes from birth, to age of 6 weeks, 6 months, 1 year and 3 years old
Trial Locations
- Locations (1)
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangdong, China