Serum Metabolomics Study of Polycystic Ovary Syndrome

NCT ID: NCT03618342

Last Updated: 2020-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-02

Study Completion Date

2020-03-31

Brief Summary

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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

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PCOS

PCOS women

No interventions assigned to this group

Healthy controls

Healthy control women

No interventions assigned to this group

Eligibility Criteria

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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

\-
Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heilongjiang University of Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yan Li

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Site Status

Countries

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China

Other Identifiers

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Metabolomics PCOS

Identifier Type: -

Identifier Source: org_study_id

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