Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology
研究概览
简要总结
The Investigator propose to develop an in-vitro technique for the measurement and analysis of freshly excised biopsies during hysteroscopy procedure in patients with suspected Chronic Endometritis (CE) condition. Furthermore, the investigator propose to develop a discrimination model between the CE and inflammatory CE types using the measured spectroscopic data from freshly excised biopsies.
详细描述
It is common practice that, following hysteroscopy, the clinician needs to wait for about two weeks before the results of the histology are returned and the clinical treatment is initiated. In this research, the investigator intent to show that the mid infrared ATR (Assisted Reproductive Treatment) spectroscopy method will provide the physician with sufficient information about the CE inflammation status in a considerably shorter period of time to allow immediate initiation of the appropriate treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
- •Patients scheduled for any histological evaluation including endometrial biopsy, dilatation and curettage (D&C), biopsy/excision of uterine polyp or fibroid or any other cervical or uterine lesion.
- •Age 18 and over.
排除标准
- •Pregnant women, minors and lack of judgment women will not included
- •At the request of the examined woman
结局指标
主要结局
Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology
时间窗: 2 Years
Using ATR-FTIR technique of impression smears obtained from CE tissue during standard hysteroscopy procedure will provide a new diagnostic tool for fast diagnosis of CE inflammation and thus assist in the clinical decision process leading to assisted reproductive treatment (ART).
次要结局
未报告次要终点