Clinical trial NCT03650829: IVF Offspring Born in Guangzhou
Official title: IVF Offspring Born in Guangzhou Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ART
Offspring, Adult
Genetics
Host and Microbiome
Neurodevelopment
Keywords: ART
Offspring
Development
Cohort
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2018-08-29
Enrollment: 3000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers conceived by ART in the BIGCS

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intelligence quotient of offspring
timeFrame: At age of 6 years old
Secondary outcomes:
measure: Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section
timeFrame: From 20 weeks of gestation to delivery
measure: Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect
timeFrame: At delivery
measure: Neurodevelopment at early childhood
timeFrame: At age of 1 year old
measure: Epegenetic profiles of offspring
timeFrame: At age of 1 year, 6 years, 12years and 18 years old
measure: Changes of body composition and bone density during early childhood
timeFrame: At age of 3 years,6 years, 12 years and 18 years old
measure: Height changes during early childhood
timeFrame: At birth, age of 6 weeks, 6 months, 1 year and 3 years old
measure: Weight changes during early childhood
timeFrame: At birth, age of 6 weeks, 6 months, 1 year and 3 years old
measure: Change of intestinal flora during early childhood
timeFrame: At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center, China
name: Xiu Qiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.