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临床试验/NCT04591548
NCT04591548已完成不适用

Biomarkers in Endometriosis

University Medical Centre Ljubljana0 个研究点目标入组 100 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Derivation of the panel of proteins indicative of endometriosis using comparative proteomics

研究概览

简要总结

Endometriosis is a common gynecological benign disease which significantly compromise quality of life in patients and is a major cofactor of infertility. With the proteomic approach the investigators will search for proteins with significantly different levels in peritoneal fluid, serum and uterine fluid samples of women with endometriosis versus control group. Results will be validate using ELISA aproach.

详细描述

Informed consent will be obtained from all individual participants included in the study. Blood sample will be obtained the day before laparoscopic surgery during regular clinical preoperative procedures. Peritoneal fluid and uterine fluid will be obtained during regular laparoscopic procedure indicated for infertility, the exact protocol of sample obtaining will be revealed after publication of results. The aim of the study was to identify potential diagnostic and predictive biomarkers or drug targets.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • primary infertility
  • normal semen analysis of the partner
  • normal BMI.

排除标准

  • hormonal therapy in the last year,
  • irregular menstrual cycle,
  • previous pelvic surgery,
  • history of previous pelvic inflammatory disease,
  • smokers and patients with autoimmune diseases,
  • malignant or suspected malignant diseases,
  • previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries

结局指标

主要结局

Derivation of the panel of proteins indicative of endometriosis using comparative proteomics

时间窗: 3 years to collect all speciments

The aim of the study is to identify proteins with different levels in cases versus controls these proteins could be new candidates for biomarkers of endometriosis. Differentially expressed proteins are candidates for diagnostic and predictive biomarkers. To identify differentially expresed proteins in discovery phase of the study proteomic aproach will be used.

次要结局

  • Concentrations of proteins in body fluids to validate the identified panel of proteins indicative of endometriosis(3 years to collect all speciments)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vid Jansa

Principal Investigator

University Medical Centre Ljubljana

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