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NCT Number: NCT03742011

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

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.

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Key information

Conditions

PCOS 46, XX Disorders of Sex Development Adrenogenital Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine Disorder Endocrine System Diseases Epigenetics Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Gonadal Disorders Hyperandrogenism Hyperinsulinism Insulin Resistance Male Urogenital Diseases Metabolic Diseases Metabolic Disturbance Nutritional and Metabolic Diseases Offspring, Adult Urogenital Abnormalities Urogenital Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)

    Time frame: An average of 3 years old

    Participants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder.

Secondary outcomes

  1. Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section

    Time frame: From the recruitment (≤ 20 weeks of gestation) to delivery

    Assessed by self-reported time of onset and electronic medical records

  2. Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect

    Time frame: At delivery

    Assessed by electronic medical records

  3. Epigenetic profiles of offspring

    Time frame: At birth

    Profiling DNA methylation and histone acetylation etc., using cord blood samples

  4. Weight changes

    Time frame: 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

  5. Height 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 from birth, to age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old

  6. 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

    Assessed by analyses of stool samples

  7. Neurodevelopment at early childhood

    Time frame: At age of 1 year old

    Assessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function

  8. Changes of the percentage of body fat

    Time frame: At age of 3 years,6 years, 12 years and 18 years old

    Assessed using Dual Energy X-Ray Absorptiometry

  9. Screen of intelligence quotient of offspring

    Time frame: 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.

  10. Intelligence quotient of offspring assessed by WPPSI-IV

    Time frame: 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.

  11. Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)

    Time frame: 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.

  12. Number of participants with reproductive endocrine disorders

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiu Qiu, PhD

CONTACT

[email protected]

0086 20 38367160

Zehong Zhou, MD

CONTACT

[email protected]

0086 20 38367160

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Collaborators

  • University of Birmingham

Registry information

Official study title

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

Acronym: PCOS-BIG

Important dates

Study start
2012
Primary completion
2025
Study completion
2038
First posted
Nov 15, 2018
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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