Serum Metabolomics Study of Polycystic Ovary Syndrome

Serum Metabolomics Study of Polycystic Ovary Syndrome Based on Liquid Chromatography-Mass Spectrometry

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03618342

Enrollment

1272

Registered

2018-08-07

Start date

2018-08-02

Completion date

2020-03-31

Last updated

2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

14 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The fatty acid amides (FAAs) metabolite changes	one year	The metabolic changes between PCOS and healthy controls

Secondary

Measure	Time frame	Description
The sulfated steroids metabolite changes	one year	The metabolic changes between PCOS and healthy controls
The free fatty acid metabolite changes	one year	The metabolic changes between PCOS and healthy controls

Countries

China

Outcome results