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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03650829
Other study ID # 2018080103
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2012
Est. completion date December 31, 2038

Study information

Verified date February 2024
Source Guangzhou Women and Children's Medical Center
Contact Xiu Qiu, PhD
Phone 0086 20 38367160
Email qxiu0161@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

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

Study Design


Locations

Country Name City State
China Guangzhou Women and Children's Medical Center Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Guangzhou Women and Children's Medical Center University of Birmingham

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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
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