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PCOSPCOS-BIGNCT03742011

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

An observational study of PCOS and Offspring, Adult, run by Guangzhou Women and Children's Medical Center at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 yearsHealthy volunteers can take part
Conditions the study is for
PCOS, Offspring, Adult, Hyperandrogenism
How many people
2,000 participants
Where
1 siteChina
Study dates
1 Feb 2012to 31 Dec 2038
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Offspring born to women diagnosed with PCOS

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiu Qiu, PhD contact

0086 20 38367160

qxiu0161@163.com

Zehong Zhou, MD contact

0086 20 38367160

rainbow_0706@163.com

China1 site, 1 recruiting

  • Guangzhou Women and Children's Medical Center, China

    Guangzhou, Guangdong, 510623

    Xiu Qiu, PhD, 0086 20 38367160, qxiu0161@163.com

    Zehong Zhou, MD, 0086 20 38367162, rainbow_0706@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Keywords
PCOS, Hyperandrogenism, Epigenetics, Glucolipid metabolism disorder
Medical subject headings
Hyperandrogenism, Insulin Resistance, Endocrine System Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: An average of 3 years old

Secondary outcomes (12)

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

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

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

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

    Assessed by electronic medical records

    Measured: At delivery

  3. Epigenetic profiles of offspring

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

    Measured: At birth

  4. Weight changes

    Weight changes from birth, to age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old

    Measured: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old

  5. Height changes

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

    Measured: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old

  6. Change of intestinal flora

    Assessed by analyses of stool samples

    Measured: At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old

  7. Neurodevelopment at early childhood

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

    Measured: At age of 1 year old

  8. Changes of the percentage of body fat

    Assessed using Dual Energy X-Ray Absorptiometry

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

  9. Screen of intelligence quotient of offspring

    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.

    Measured: At age of 6 years old

  10. Intelligence quotient of offspring assessed by WPPSI-IV

    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.

    Measured: At age of 6 years old

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

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

    Measured: At age of 6 years, 12 years and 18 years old

  12. Number of participants with reproductive endocrine disorders

    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.

    Measured: At age of 12 years and 18 years old

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start1 Feb 2012
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742011
Sponsor's protocol ID
2018101502
Acronym
PCOS-BIG
Status last verified
Feb 2024
First submitted
29 Oct 2018
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou Z, Li R, Qiao J. Androgen profile in Chinese women with polycystic ovary syndrome in their reproductive years. Reprod Biomed Online. 2017 Sep;35(3):331-339. doi: 10.1016/j.rbmo.2017.05.019. Epub 2017 Jun 16.

    PubMed 28684272

  • Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20.

    PubMed 28321694

Questions about this trial

What is this clinical trial studying?

An observational study of PCOS and Offspring, Adult, run by Guangzhou Women and Children's Medical Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiu Qiu, PhD (0086 20 38367160, qxiu0161@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders) (time frame: An average of 3 years old). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03742011, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.

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