NCT01351051已完成不适用
A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 1,008
- 试验地点
- 7
- 主要终点
- Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.
研究概览
简要总结
This study will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures.
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
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject is a female aged between 18 and 41 years
- •The subject has undergone a laparoscopy or laparotomy for a benign gynecological indication excluding pregnancy, in the last 3 months
- •The subject's surgery showed either no visible endometriosis lesions or histologically confirmed endometriosis lesions: superficial endometriosis, endometrioma or deep infiltrating endometriosis
- •The subject has given a written informed consent prior to any study-related procedures
排除标准
- •The subject is pregnant
- •The subject's surgery results showed evidence of malignancy
- •The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or with evidence of an uncooperative attitude
结局指标
主要结局
Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.
时间窗: Enrolment visit
次要结局
- Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire.(Enrolment visit)
- Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire.(Enrolment visit)
- Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire.(Enrolment visit)
研究者
研究点 (7)
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