An observational study in PCOS, Offspring, Adult and Hyperandrogenism, sponsored by Guangzhou Women and Children's Medical Center. Recruiting at 1 site in China. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Guangzhou Women and Children's Medical Center · Observational
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.
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.
81 studies on the registry are indexed under Hyperandrogenism; 22 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 135 across 26 observational studies indexed under Hyperandrogenism.
Browse Hyperandrogenism studies →Guangzhou Women and Children's Medical Center is the lead sponsor of 58 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Offspring born to women diagnosed with PCOS
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: An average of 3 years old
Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section
Assessed by self-reported time of onset and electronic medical records
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
Assessed by electronic medical records
Time frame: At delivery
Epigenetic profiles of offspring
Profiling DNA methylation and histone acetylation etc., using cord blood samples
Time frame: 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
Time frame: 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
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
Assessed by analyses of stool samples
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
Assessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function
Time frame: At age of 1 year old
Changes of the percentage of body fat
Assessed using Dual Energy X-Ray Absorptiometry
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At age of 12 years and 18 years old
Plan to share: No
Started Feb 2012 (actual). Primary completion is estimated for Dec 2025, 166 months after the start.
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Guangzhou Women and Children's Medical Center