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

IRCCS Sacro Cuore Don Calabria di Negrar845 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

845

Conditions

Endometriosis

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria 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. Exclusion Criteria for both groups: * lack of signed informed consent; * Menopause * antibiotic therapy in the 30 days before samples collection (including vaginal and cervical swab).