Serum Metabolomics Study of Polycystic Ovary Syndrome

• Sponsor: Heilongjiang University of Chinese Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03618342
• Collaborator: (none)
• Enrollment: 1,272
• Location: 1
• Anticipated Duration (Months): 19.9
• Patients Per Site Per Month: 63.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome

Study Design

• Study Type: Observational
• Actual Enrollment: 1272 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Serum Metabolomics Study of Polycystic Ovary Syndrome Based on Liquid Chromatography-Mass Spectrometry
• Actual Study Start Date: Aug 2, 2018
• Actual Primary Completion Date: Aug 31, 2019
• Anticipated Study Completion Date: Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
PCOS PCOS women
Healthy controls Healthy control women

Outcome Measures

Primary Outcome Measures

1. The fatty acid amides (FAAs) metabolite changes [one year]

   The metabolic changes between PCOS and healthy controls

Secondary Outcome Measures

1. The sulfated steroids metabolite changes [one year]

   The metabolic changes between PCOS and healthy controls

2. The free fatty acid metabolite changes [one year]

   The metabolic changes between PCOS and healthy controls

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang	China	150040

Sponsors and Collaborators

• Heilongjiang University of Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yan Li, Doctor, Heilongjiang University of Chinese Medicine
• ClinicalTrials.gov Identifier: NCT03618342
• Other Study ID Numbers: Metabolomics PCOS
• First Posted: Aug 7, 2018
• Last Update Posted: Mar 23, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome

Study Results

No Results Posted as of Mar 23, 2020