Clinical trial NCT06368596: ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis
Official title: ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 845
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis
timeFrame: At surgical intervention
Secondary outcomes:
measure: Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis
timeFrame: At surgical intervention
measure: Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled
timeFrame: At preoperative visit
measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis .
timeFrame: At surgical intervention
measure: Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present
timeFrame: At surgical intervention
measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis
timeFrame: At surgical intervention
measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis
timeFrame: At surgical intervention
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria di Negrar
state: Verona
Study officials:
References: