NCT06368596

ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 845 (estimated)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fusobacterium detection	One vaginal and one cervical swab will be collected from participants (both cases and controls) before surgery. During surgical intervention, routine biopsies of the endometriotic tissue will be done for all endometriosis types; further, small biopsies of apparently healthy endometrial tissue and of healthy peritoneum will be done, as per routine procedure. In the control group routine biopsies needed for the specific condition and small biopsies of endometrial tissue will be carried out. During these routine biopsies, a small additional quantity of tissue will be taken, which will be analyzed for the search for Fusobacterium.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: Italy