ARTIVF-BIGNCT03650829
IVF Offspring Born in Guangzhou
An observational study of ART and Offspring, Adult, run by Guangzhou Women and Children's Medical Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ART, Offspring, Adult, Genetics
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Mothers conceived by ART in the BIGCS
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Xiu Qiu, PhD, 0086 20 38367162, qxiu0161@163.com
Zehong Zhou, MD, 0086 20 38367162, rainbow_0706@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- ART, Offspring, Adult, Genetics, Host and Microbiome, Neurodevelopment
- Keywords
- ART, Offspring, Development, Cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At age of 6 years old
Secondary outcomes (8)
Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section
Assessed by self-reported time of onset and electronic medical records
Measured: From 20 weeks of gestation to delivery
Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect
Assesed by electronic records
Measured: At delivery
Neurodevelopment at early childhood
Assessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function
Measured: At age of 1 year old
Epegenetic profiles of offspring
Profiling DNA methylation and histone acetylation etc., using blood samples
Measured: At age of 1 year, 6 years, 12years and 18 years old
Changes of body composition and bone density during early childhood
Assessed using Dual Energy X-Ray Absorptiometry
Measured: At age of 3 years,6 years, 12 years and 18 years old
Height changes during early childhood
Height changes from birth, to age of 6 weeks, 6 months, 1 year and 3 years old
Measured: At birth, age of 6 weeks, 6 months, 1 year and 3 years old
Weight changes during early childhood
Weight changes from birth, to age of 6 weeks, 6 months, 1 year and 3 years old
Measured: At birth, age of 6 weeks, 6 months, 1 year and 3 years old
Change of intestinal flora during early childhood
Assessed by analyses of stool samples
Measured: At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Feb 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Xiu Qiu, Guangzhou Women and Children's Medical Center
- Investigators
- Xiu Qiu, PhD, Principal investigator, Guangzhou Women and Children's Medical Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650829
- Sponsor's protocol ID
- 2018080103
- Acronym
- IVF-BIG
- Status last verified
- Feb 2024
- First submitted
- 27 Aug 2018
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28321694
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF Offspring Born in Guangzhou Cohort Study
- ClinicalTrials.gov ID
- NCT03650829
- Acronym / sponsor ID
- IVF-BIG / 2018080103
- Conditions
- ART, Offspring, Adult, Genetics, Host and Microbiome, Neurodevelopment
- Keywords
- ART, Offspring, Development, Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Mothers conceived by ART in the BIGCS
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section
Time frame: 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
Neurodevelopment at early childhood
Time frame: At age of 1 year old
Epegenetic profiles of offspring
Time frame: 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
Height changes during early childhood
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 28321694Qiu 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.
- Related websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiu Qiu, PhD principal investigator
Guangzhou Women and Children's Medical Center, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ART and Offspring, Adult, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiu Qiu, PhD (0086 20 38367160, qxiu0161@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intelligence quotient of offspring (time frame: At age of 6 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03650829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024; AzTrials last refreshed its copy on 2 Nov 2026.