ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis
- Conditions
- Endometriosis
- Interventions
- Diagnostic Test: Fusobacterium detection
- Registration Number
- NCT06368596
- Lead Sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 845
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study arm Fusobacterium detection Patients in reproductive age, who will undergo elective surgery for endometriosis. Control arm Fusobacterium detection Women in reproductive age, without endometriosis, as control group for secondary objective 1 and 2.
- Primary Outcome Measures
Name Time Method Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis At surgical intervention
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
IRCCS Sacro Cuore Don Calabria di Negrar
🇮🇹Negrar, Verona, Italy