IVF Offspring Born in Guangzhou

Study Overview
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Brief Summary
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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
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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.

Official Title
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IVF Offspring Born in Guangzhou Cohort Study

Conditions
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ART, Offspring, Adult, Genetics, Host and Microbiome, Neurodevelopment

Participation Criteria
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Eligibility Criteria
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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: • None

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intelligence quotient of offspring | 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 | At age of 6 years old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section | Assessed by self-reported time of onset and electronic medical records | From 20 weeks of gestation to delivery | 
| Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect | Assesed by electronic records | At delivery | 
| Neurodevelopment at early childhood | Assessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function | At age of 1 year old | 
| Epegenetic profiles of offspring | Profiling DNA methylation and histone acetylation etc., using blood samples | At age of 1 year, 6 years, 12years and 18 years old | 
| Changes of body composition and bone density during early childhood | Assessed using Dual Energy X-Ray Absorptiometry | At age of 3 years,6 years, 12 years and 18 years old | 
| Height changes during early childhood | Height changes from birth, to age of 6 weeks, 6 months, 1 year and 3 years old | At birth, age of 6 weeks, 6 months, 1 year and 3 years old | 
| Weight changes during early childhood | Weight changes from birth, to age of 6 weeks, 6 months, 1 year and 3 years old | At birth, age of 6 weeks, 6 months, 1 year and 3 years old | 
| Change of intestinal flora during early childhood | Assessed by analyses of stool samples | At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ART, Offspring, Development, Cohort