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IVF Offspring Born in Guangzhou

IVF Offspring Born in Guangzhou Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03650829
Acronym
IVF-BIG
Enrollment
3000
Registered
2018-08-29
Start date
2012-02-01
Completion date
2038-12-31
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ART, Offspring, Development, Cohort

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.

Detailed 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.

Interventions

None listed

Sponsors

University of Birmingham
CollaboratorOTHER
Guangzhou Women and Children's Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Intelligence quotient of offspringAt age of 6 years oldAssessed 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

Secondary

MeasureTime frameDescription
Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defectAt deliveryAssesed by electronic records
Neurodevelopment at early childhoodAt age of 1 year oldAssessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function
Epegenetic profiles of offspringAt age of 1 year, 6 years, 12years and 18 years oldProfiling DNA methylation and histone acetylation etc., using blood samples
Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean sectionFrom 20 weeks of gestation to deliveryAssessed by self-reported time of onset and electronic medical records
Height changes during early childhoodAt birth, age of 6 weeks, 6 months, 1 year and 3 years oldHeight changes from birth, to age of 6 weeks, 6 months, 1 year and 3 years old
Weight changes during early childhoodAt birth, age of 6 weeks, 6 months, 1 year and 3 years oldWeight changes from birth, to age of 6 weeks, 6 months, 1 year and 3 years old
Change of intestinal flora during early childhoodAt age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years oldAssessed by analyses of stool samples
Changes of body composition and bone density during early childhoodAt age of 3 years,6 years, 12 years and 18 years oldAssessed using Dual Energy X-Ray Absorptiometry

Countries

China

Contacts

Primary ContactXiu Qiu, PhD
qxiu0161@163.com0086 20 38367160
Backup ContactZehong Zhou, MD
rainbow_0706@163.com0086 20 38367160

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026