Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: PCOS, Offspring, Adult, Hyperandrogenism, Epigenetics. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Health of Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study
Overview
The Offspring Born to Mothers with Polycystic Ovary Syndrome in Guangzhou Cohort study (PCOS-BIG) was established to investigate the short- and long-term effects of intrauterine exposure to maternal PCOS on the health of offspring in Guangzhou, China. Data are collected regarding maternal PCOS subtypes, nursing, diet and education as well as health outcomes in their later life. Biological samples including blood and tissue samples are also collected from participants.
Detailed description
According to preliminary survey, the prevalence of polycystic ovary syndrome (PCOS) among Chinese women reached 7.5%. Hyperandrogenism and insulin resistance were considered as the main pathogenesis of PCOS. As reported, the secretion of androgen is higher among women with PCOS than the healthy reference population throughout their fertile lives. Worth of concern, offspring of PCOS patients presented with glucolipid metabolism disorders as early as during their childhood, while whose pathogenesis remains unclear. Prenatal exposure of rhesus monkey in pregnant to androgens produces glucolipid metabolic alterations in offspring resembling those in PCOS, suggesting that the exposure of the fetus to hyperandrogenism during gestation could affect the glucolipid metabolism of PCOS offspring. Growing evidence shows that different exposures during pregnancy will affect the DNA methylation of offspring and disturb their endocrine and metabolism. A birth cohort would provide an opportunity to examine the short- and long-term effects of PCOS exposure, such as hyperandrogenism, on health consequences of the offspring.
Primary outcome measures
- Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders) [Time frame: An average of 3 years old]
Secondary outcome measures (12)
- Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section [Time frame: From the recruitment (≤ 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]
- Epigenetic profiles of offspring [Time frame: At birth]
- Weight changes [Time frame: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old]
- Height changes [Time frame: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old]
- Change of intestinal flora [Time frame: At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old]
- Neurodevelopment at early childhood [Time frame: At age of 1 year old]
- Changes of the percentage of body fat [Time frame: At age of 3 years,6 years, 12 years and 18 years old]
- Screen of intelligence quotient of offspring [Time frame: At age of 6 years old]
- Intelligence quotient of offspring assessed by WPPSI-IV [Time frame: At age of 6 years old]
- Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders) [Time frame: At age of 6 years, 12 years and 18 years old]
- Number of participants with reproductive endocrine disorders [Time frame: At age of 12 years and 18 years old]
Eligibility criteria
Inclusion criteria
- Offspring born to women diagnosed with PCOS
- Offspring born to women with <20 weeks of gestation, intended to eventually deliver in Guangzhou Women and Children's Medical Center
- Permanent residents or families intended to remain in Guangzhou for ≥3 years
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Guangzhou Women and Children's Medical Center, China — Guangzhou
Publications
- Zhou Z, Li R, Qiao J. Androgen profile in Chinese women with polycystic ovary syndrome in their reproductive years. Reprod Biomed Online. 2017 Sep;35(3):331-339. doi: 10.1016/j.rbmo.2017.05.019. Epub 2017 Jun 16. PMID 28684272
- 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. PMID 28321694
Identifiers
NCT: NCT03742011 · 2018101502