ART Clinical Trial
— IVF-BIGOfficial title:
IVF Offspring Born in Guangzhou Cohort Study
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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | December 31, 2038 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangzhou Women and Children's Medical Center | University of Birmingham |
China,
Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-02 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect | Assesed by electronic records | At delivery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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