Clinical trial NCT03742011: Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study
Official title: Health of Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PCOS
Offspring, Adult
Hyperandrogenism
Epigenetics
Insulin Resistance
Endocrine Disorder
Metabolic Disturbance
Keywords: PCOS
Hyperandrogenism
Epigenetics
Glucolipid metabolism disorder
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2018-11-15
Enrollment: 2000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Offspring born to women diagnosed with PCOS

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)
timeFrame: An average of 3 years old
Secondary outcomes:
measure: Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section
timeFrame: From the recruitment (≤ 20 weeks of gestation) to delivery
measure: Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect
timeFrame: At delivery
measure: Epigenetic profiles of offspring
timeFrame: At birth
measure: Weight changes
timeFrame: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
measure: Height changes
timeFrame: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
measure: Change of intestinal flora
timeFrame: At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
measure: Neurodevelopment at early childhood
timeFrame: At age of 1 year old
measure: Changes of the percentage of body fat
timeFrame: At age of 3 years,6 years, 12 years and 18 years old
measure: Screen of intelligence quotient of offspring
timeFrame: At age of 6 years old
measure: Intelligence quotient of offspring assessed by WPPSI-IV
timeFrame: At age of 6 years old
measure: Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)
timeFrame: At age of 6 years, 12 years and 18 years old
measure: Number of participants with reproductive endocrine disorders
timeFrame: At age of 12 years and 18 years old
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center, China
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center, China
name: Xiu Qiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.