Serum Metabolomics Study of Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03618342
• Other study ID #: Metabolomics PCOS
• Status: Active, not recruiting
• Start date: August 2, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2020
• Source: Heilongjiang University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1272
• Est. completion date: March 31, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 40 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
China	First Affiliated Hospital, Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The fatty acid amides (FAAs) metabolite changes	The metabolic changes between PCOS and healthy controls	one year
Secondary	The sulfated steroids metabolite changes	The metabolic changes between PCOS and healthy controls	one year
Secondary	The free fatty acid metabolite changes	The metabolic changes between PCOS and healthy controls	one year