Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03742011
Acronym
PCOS-BIG
Enrollment
2000
Registered
2018-11-15
Start date
2012-02-01
Completion date
2038-12-31
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PCOS, Hyperandrogenism, Epigenetics, Glucolipid metabolism disorder

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.

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.

Interventions

None listed

Sponsors

University of Birmingham
CollaboratorOTHER
Guangzhou Women and Children's Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
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

Exclusion criteria

* None

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defectAt deliveryAssessed by electronic medical records
Epigenetic profiles of offspringAt birthProfiling DNA methylation and histone acetylation etc., using cord blood samples
Weight changesAt birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years oldWeight changes from birth, to age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
Height changesAt birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years oldHeight 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 floraAt age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years oldAssessed by analyses of stool samples
Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean sectionFrom the recruitment (≤ 20 weeks of gestation) to deliveryAssessed by self-reported time of onset and electronic medical records
Changes of the percentage of body fatAt age of 3 years,6 years, 12 years and 18 years oldAssessed using Dual Energy X-Ray Absorptiometry
Screen of intelligence quotient of offspringAt age of 6 years oldAssessed 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-IVAt age of 6 years oldChild 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 oldParticipants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder.
Number of participants with reproductive endocrine disordersAt age of 12 years and 18 years oldAssessed 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.
Neurodevelopment at early childhoodAt age of 1 year oldAssessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function

Countries

China

Contacts

Primary ContactXiu Qiu, PhD
qxiu0161@163.com0086 20 38367160
Backup ContactZehong Zhou, MD
rainbow_0706@163.com0086 20 38367160

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026