IVF Offspring Born in Guangzhou

ART Clinical Trial

— IVF-BIG  

Official title:

IVF Offspring Born in Guangzhou Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03650829
• Other study ID #: 2018080103
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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

External Links

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