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临床试验/NCT03618342
NCT03618342Unknown不适用

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

Heilongjiang University of Chinese Medicine1 个研究点 分布在 1 个国家目标入组 1,272 人开始时间: 2018年8月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,272
试验地点
1
主要终点
The fatty acid amides (FAAs) metabolite changes

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
14 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

The fatty acid amides (FAAs) metabolite changes

时间窗: one year

The metabolic changes between PCOS and healthy controls

次要结局

  • The free fatty acid metabolite changes(one year)
  • The sulfated steroids metabolite changes(one year)

研究者

发起方
Heilongjiang University of Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yan Li

Doctor

Heilongjiang University of Chinese Medicine

研究点 (1)

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