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NCT Number: NCT03650829

IVF Offspring Born in Guangzhou

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.

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Key information

Conditions

ART Genetics Host and Microbiome Neurodevelopment Offspring, Adult

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intelligence quotient of offspring

    Time frame: At age of 6 years old

    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

Secondary outcomes

  1. Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section

    Time frame: From 20 weeks of gestation to delivery

    Assessed by self-reported time of onset and electronic medical records

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

    Time frame: At delivery

    Assesed by electronic records

  3. Neurodevelopment at early childhood

    Time frame: At age of 1 year old

    Assessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function

  4. Epegenetic profiles of offspring

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

    Profiling DNA methylation and histone acetylation etc., using blood samples

  5. Changes of body composition and bone density during early childhood

    Time frame: At age of 3 years,6 years, 12 years and 18 years old

    Assessed using Dual Energy X-Ray Absorptiometry

  6. Height changes during early childhood

    Time frame: At birth, age of 6 weeks, 6 months, 1 year and 3 years old

    Height changes from birth, to age of 6 weeks, 6 months, 1 year and 3 years old

  7. Weight changes during early childhood

    Time frame: At birth, age of 6 weeks, 6 months, 1 year and 3 years old

    Weight changes from birth, to age of 6 weeks, 6 months, 1 year and 3 years old

  8. Change of intestinal flora during early childhood

    Time frame: At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old

    Assessed by analyses of stool samples

Study contacts

Contact information is provided by the study sponsor or research team.

Xiu Qiu, PhD

CONTACT

[email protected]

0086 20 38367160

Zehong Zhou, MD

CONTACT

[email protected]

0086 20 38367160

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Collaborators

  • University of Birmingham

Registry information

Official study title

IVF Offspring Born in Guangzhou Cohort Study

Acronym: IVF-BIG

Important dates

Study start
2012
Primary completion
2025
Study completion
2038
First posted
Aug 29, 2018
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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