ClinicalTrials.gov record NCT03742011

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Feb 26, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
AgeUp to 18 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A prospective birth cohort that follows children born to women diagnosed with polycystic ovary syndrome (PCOS) to study possible short- and long-term health effects of prenatal exposure to maternal PCOS. The study gathers maternal information, medical records, questionnaires on feeding/diet/education, and biological samples, and follows children with repeated assessments through childhood and adolescence. Measures include growth, metabolic and reproductive hormone tests, epigenetic profiling, intestinal flora analysis, neurodevelopmental screening and body-composition scans.

What it is studying. Whether and how prenatal exposure to maternal PCOS (including features such as hyperandrogenism and insulin-resistance-related factors) is associated with offspring outcomes: growth, glucose and lipid metabolism, reproductive endocrine measures, epigenetic marks, intestinal flora, neurodevelopment and body composition over time.

What the researchers hope to learn. To define short- and long-term associations between maternal PCOS exposure and offspring health; to measure prevalence of metabolic and reproductive endocrine differences in offspring; and to characterize epigenetic and intestinal-flora profiles related to those outcomes.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Mothers are enrolled before 20 weeks' gestation and their children are followed from birth through age 18 with scheduled visits. At birth the study collects cord blood and other biological samples; across childhood it collects blood and tissue samples, stool samples, and records growth (weight and height) at multiple ages. Participants may have DXA scans for body fat at set ages and undergo developmental and IQ testing (for example at 1 and 6 years); researchers will also review medical records and run laboratory tests for glucolipid metabolism and reproductive hormones at planned ages. The registry does not list additional participant support services.

How the study is structured. A prospective observational cohort. Children born to women with PCOS are followed from birth with scheduled visits at multiple ages up to 18 years. The study collects clinical records and questionnaires, takes biological samples (cord blood, blood, stool, and tissue), and performs repeated assessments such as lab tests for metabolism and reproductive hormones, DNA methylation/histone acetylation profiling, stool analyses, growth measurements, DXA body-fat scans, developmental tests, and IQ screening.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under PCOS; Offspring, Adult; Hyperandrogenism; Epigenetics; Insulin Resistance; Endocrine Disorder; Metabolic Disturbance. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Feb 1, 2012
Primary completion
Dec 31, 2025 (estimated)
Study completion
Dec 31, 2038 (estimated)
Target enrollment
2000 participants (estimated)
Last updated on registry
Feb 26, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Guangzhou Women and Children's Medical Center
Principal investigator
Xiu Qiu, Director of the Born in Guangzhou Cohort Study
Guangzhou Women and Children's Medical Center
Collaborators
  • University of Birmingham

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Cohort study
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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