Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Health of Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study

Conditions
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PCOS, Offspring, Adult, Hyperandrogenism, Epigenetics, Insulin Resistance, Endocrine Disorder, Metabolic Disturbance

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders) | Participants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder. | An average of 3 years old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section | Assessed by self-reported time of onset and electronic medical records | 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 | Assessed by electronic medical records | At delivery | 
| Epigenetic profiles of offspring | Profiling DNA methylation and histone acetylation etc., using cord blood samples | At birth | 
| Weight changes | Weight changes from birth, to age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old | At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old | 
| Height changes | Height changes from birth, to age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old | At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old | 
| Change of intestinal flora | 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 | 
| Neurodevelopment at early childhood | Assessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function | At age of 1 year old | 
| Changes of the percentage of body fat | Assessed using Dual Energy X-Ray Absorptiometry | At age of 3 years,6 years, 12 years and 18 years old | 
| Screen of intelligence quotient of offspring | Assessed using Peabody Picture Vocabulary Test (PPVT) and Raven's Standard Progressive Matrices (SPM). Of whom the score of PPVT ≥ 85 and the score of SPM ≥ 90, the child will be considered as normal level of intelligence quotient and of whom the score of PPVT under 85 or the score of SPM under 90 will be considered as suspected lower intelligence quotient. | At age of 6 years old | 
| Intelligence quotient of offspring assessed by WPPSI-IV | Child screened as of suspected lower intelligence quotient will be assessed by Wechsler Preschool and Primary Scale of Intelligence-Fourth edition (WPPSI-IV), including 5 items: verbal comprehension, visual spatial, fluid reasoning, working memory and process speed. Scores of the five items are added to get the total score. | At age of 6 years old | 
| Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders) | Participants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder. | At age of 6 years, 12 years and 18 years old | 
| Number of participants with reproductive endocrine disorders | Assessed by assay of hormones, including follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), total testosterone (TT), free testosterone (FT), androstenedione (A4), dehydroepiandrosterone sulfate (DHEA-S) and sex hormone binding globulin (SHBG), and by acne scoring and hirsutism scoring (modified Ferriman-Gallway scoring system). Participants with one or more abnormal laboratory values, and/or acne score ≥ 1, and/or hirsutism score ≥ 5 will be considered as with reproductive endocrine disorder. | At age of 12 years and 18 years old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Hyperandrogenism, Epigenetics, Glucolipid metabolism disorder