NCT06368596Unknown不适用
ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis
IRCCS Sacro Cuore Don Calabria di Negrar1 个研究点 分布在 1 个国家目标入组 845 人开始时间: 2024年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 845
- 试验地点
- 1
- 主要终点
- Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis
研究概览
简要总结
This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation.
A control group would however be recruited for secondary objective 1 and 2.
The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •for study group:
- •Age ≥ 18 years;
- •endometriosis with clinical indication for either hysteroscopy or hysterectomy;
- •signed informed consent to study participation and to personal data's treatment.
- •Inclusion Criteria for control group:
- •need of elective gynecological surgery for causes other than endometriosis and malignancies;
- •indication for hysteroscopy with endometrial biopsy;
- •signed informed consent to study participation and to personal data's treatment.
排除标准
- •for both groups:
- •lack of signed informed consent;
- •Menopause
- •antibiotic therapy in the 30 days before samples collection (including vaginal and cervical swab).
结局指标
主要结局
Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis
时间窗: At surgical intervention
次要结局
- Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis .(At surgical intervention)
- Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis(At surgical intervention)
- Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled(At preoperative visit)
- Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present(At surgical intervention)
- Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis(At surgical intervention)
- Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis(At surgical intervention)
研究者
研究点 (1)
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