NCT03742011

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
154mo left

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2012Dec 2038

Study Start

First participant enrolled

February 1, 2012

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2038

Expected
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

13.9 years

First QC Date

October 29, 2018

Last Update Submit

February 22, 2024

Conditions

PCOSOffspring, AdultHyperandrogenismEpigeneticsInsulin ResistanceEndocrine DisorderMetabolic Disturbance

Keywords

PCOSHyperandrogenismEpigeneticsGlucolipid metabolism disorder

Outcome Measures

Primary Outcomes (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.

    An average of 3 years old

Secondary Outcomes (12)

  • Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section

    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

    At delivery

  • Epigenetic profiles of offspring

    At birth

  • Weight changes

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

  • Height changes

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

  • +7 more secondary outcomes

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Offspring born to women diagnosed with PCOS

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's Medical Center, China

Guangzhou, Guangdong, 510623, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28684272BACKGROUND

  • 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.

    PMID: 28321694RESULT

Biospecimen

Retention: SAMPLES WITH DNA

During pregnancy: maternal blood, urine and stool. At delivery: cord, cord blood and placenta. During Infancy：dry blood spot, stool and blood. During childhood:blood, buccal swab and stool.

MeSH Terms

Conditions

HyperandrogenismInsulin ResistanceEndocrine System Diseases

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Xiu Qiu, PhD

    Guangzhou Women and Children's Medical Center, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiu Qiu, PhD

CONTACT

0086 20 38367160qxiu0161@163.com

Zehong Zhou, MD

CONTACT

0086 20 38367160rainbow_0706@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Born in Guangzhou Cohort Study

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 15, 2018

Study Start

February 1, 2012

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2038

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)