Serum Metabolomics Study of Polycystic Ovary Syndrome

H

Heilongjiang University of Chinese Medicine

Status

Unknown

Conditions

Polycystic Ovary Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT03618342
Metabolomics PCOS

Details and patient eligibility

About

Polycystic ovary syndrome (PCOS) is a complex, heterogeneous disorder, which produces in 5-20% reproductive age women. In this study, a nontargeted metabolomics approach based on ultra high-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry will be used to investigate serum metabolic characteristics of PCOS. PCOS women and healthy control will be divided into two distinct groups based on multivariate statistical analysis. The findings of this study will offer a new insight to understand the pathogenesis mechanism, and the discriminating metabolites may provide a prospect for PCOS diagnosis.

Enrollment

1,272 patients

Sex

Female

Ages

14 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • PCOS diagnostic criteria: According to the diagnostic criteria revised by the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine at the Rotterdam in 2003,4 PCOS patients can be diagnosed if two of the three criteria are present after excluding congenial adrenal hyperplasia, Cushing's syndrome, androgen secreting tumors, or other related disorders. The three criteria are (1) oligo- and/or anovulation; (2) clinical and/or biochemical signs of hyperandrogenism (clinical manifestations of hyperandrogenism include presence of acne, hirsutism, and androgenic alopecia); (3) polycystic ovaries by ultrasound examination: presence of 12 or more follicles in each ovary measuring 2-9 mm on diameter and/or ovarian volume>10 ml.
  • Age between 14 and 40 years
  • 2 years after menarche

Exclusion criteria

Trial design

1,272 participants in 2 patient groups

PCOS
Description:
PCOS women
Healthy controls
Description:
Healthy control women

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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