IVF Offspring Born in Guangzhou

NCT03650829 | Recruiting DMC

• 1 other identifier: 2018080103
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ART; Offspring; Development; Cohort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section

  From 20 weeks of gestation to delivery

• Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect

  At delivery

• Neurodevelopment at early childhood

  At age of 1 year old

• Epegenetic profiles of offspring

  At age of 1 year, 6 years, 12years and 18 years old

• Changes of body composition and bone density during early childhood

  At age of 3 years,6 years, 12 years and 18 years old

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mothers conceived by ART in the BIGCS

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead
• University of Birmingham: collaborator

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

RECRUITING

Related 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/s10654-017-0239-x. Epub 2017 Mar 20.

  PMID: 28321694 RESULT

Related Links

• Related website

Biospecimen

Retention: SAMPLES WITH DNA

During pregnancy: maternal blood, urine and stool. At delivery: cord, cord blood and placenta. During Infancy：dry blood spot, stool and blood. During childhood:blood, buccal swab and stool.

Study Officials

• Xiu Qiu, PhD

  Guangzhou Women and Children's Medical Center, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiu Qiu, PhD

CONTACT

0086 20 38367160; qxiu0161@163.com

Zehong Zhou, MD

CONTACT

0086 20 38367160; rainbow_0706@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Born in Guangzhou Cohort Study

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: February 1, 2012
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2038
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)