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

February 22, 2024 updated by: Xiu Qiu, Guangzhou Women and Children's Medical Center

Health of 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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Recruiting
        • Guangzhou Women and Children's Medical Center, China
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Offspring born to women diagnosed with PCOS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
An average of 3 years old

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At age of 1 year old
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
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
Time Frame: At delivery
Assessed by electronic medical records
At delivery
Epigenetic profiles of offspring
Time Frame: At birth
Profiling DNA methylation and histone acetylation etc., using cord blood samples
At birth
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
At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
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
At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
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
At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
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
At age of 3 years,6 years, 12 years and 18 years old
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.
At age of 6 years old
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.
At age of 6 years old
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.
At age of 6 years, 12 years and 18 years old
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.
At age of 12 years and 18 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Collaborators

University of Birmingham

Investigators

  • Principal Investigator: Xiu Qiu, PhD, Guangzhou Women and Children's Medical Center, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018101502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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