PCOS-BIG: Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study

Sponsor

Guangzhou Women and Children's Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03742011

Collaborator

University of Birmingham (Other)

2,000

Enrollment

Location

323

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
PCOS Offspring, Adult Hyperandrogenism Epigenetics Insulin Resistance Endocrine Disorder Metabolic Disturbance

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2012

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2038

Outcome Measures

Primary Outcome Measures

Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders) [An average of 3 years old]
Participants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder.

Secondary Outcome Measures

Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section [From the recruitment (≤ 20 weeks of gestation) to delivery]
Assessed by self-reported time of onset and electronic medical records
Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect [At delivery]
Assessed by electronic medical records
Epigenetic profiles of offspring [At birth]
Profiling DNA methylation and histone acetylation etc., using cord blood samples
Weight changes [At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old]
Weight changes from birth, to age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
Height changes [At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old]
Height changes from birth, to age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
Change of intestinal flora [At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old]
Assessed by analyses of stool samples
Neurodevelopment at early childhood [At age of 1 year old]
Assessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function
Changes of the percentage of body fat [At age of 3 years,6 years, 12 years and 18 years old]
Assessed using Dual Energy X-Ray Absorptiometry
Screen of intelligence quotient of offspring [At age of 6 years old]
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.
Intelligence quotient of offspring assessed by WPPSI-IV [At age of 6 years old]
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.
Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders) [At age of 6 years, 12 years and 18 years old]
Participants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder.
Number of participants with reproductive endocrine disorders [At age of 12 years and 18 years old]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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