Serum Metabolomics Study of Polycystic Ovary Syndrome

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT03618342
• Lead Sponsor: Heilongjiang University of Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-01
• Study Start: 2018-08-02
• Study First Submitted QC: 2018-08-04
• Study First Posted: 2018-08-07
• Primary Completion: 2019-08-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1272

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The fatty acid amides (FAAs) metabolite changes	one year	The metabolic changes between PCOS and healthy controls

Secondary Outcome Measures

Name	Time	Method
The free fatty acid metabolite changes	one year	The metabolic changes between PCOS and healthy controls
The sulfated steroids metabolite changes	one year	The metabolic changes between PCOS and healthy controls

Trial Locations

Locations (1)

First Affiliated Hospital, Heilongjiang University of Chinese Medicine; 🇨🇳 Harbin, Heilongjiang, China