Serum Metabolomics Study of Polycystic Ovary Syndrome
1 other identifier
observational
1,272
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2018
CompletedStudy Start
First participant enrolled
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedMarch 23, 2020
March 1, 2020
1.1 years
August 1, 2018
March 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The fatty acid amides (FAAs) metabolite changes
The metabolic changes between PCOS and healthy controls
one year
Secondary Outcomes (2)
The sulfated steroids metabolite changes
one year
The free fatty acid metabolite changes
one year
Study Arms (2)
PCOS
PCOS women
Healthy controls
Healthy control women
Eligibility Criteria
PCOS is a complex disease and its pathogenesis is not clear, but it is believed to be the result from genetic, environmental, and lifestyle interaction. It is relatively clear that PCOS is closely related with hormone abnormality. More and more evidence displayed that insulin signaling pathways are closely related to PCOS. PCOS may also be associated with chronic inflammation and increased level of oxidative stress.
You may qualify if:
- 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
- years after menarche
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
August 1, 2018
First Posted
August 7, 2018
Study Start
August 2, 2018
Primary Completion
August 31, 2019
Study Completion
March 31, 2020
Last Updated
March 23, 2020
Record last verified: 2020-03