IVF Offspring Born in Guangzhou (IVF-BIG)

February 22, 2024 updated by: Xiu Qiu, Guangzhou Women and Children's Medical Center

IVF Offspring Born in Guangzhou Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Recruiting
        • Guangzhou women and children's medical center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Mothers conceived by ART in the BIGCS

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At age of 6 years old

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
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
From 20 weeks of gestation to delivery
Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect
Time Frame: At delivery
Assesed by electronic records
At delivery
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
At age of 1 year old
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
At age of 1 year, 6 years, 12years and 18 years old
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
At age of 3 years,6 years, 12 years and 18 years old
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
At birth, age of 6 weeks, 6 months, 1 year and 3 years old
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
At birth, age of 6 weeks, 6 months, 1 year and 3 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Collaborators

University of Birmingham

Investigators

  • Principal Investigator: Xiu Qiu, PhD, Guangzhou Women and Children's Medical Center, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018080103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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