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

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Not yet enrolling

Conditions: Endometriosis

Treatments: Diagnostic Test: Fusobacterium detection

Study type: Interventional

Funder types: Other

Identifiers

NCT06368596

2024-04

Details and patient eligibility

About

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.

Enrollment: 845 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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845 participants in 2 patient groups

Study arm

Other group

Description:

Patients in reproductive age, who will undergo elective surgery for endometriosis.

Treatment:

Diagnostic Test: Fusobacterium detection

Control arm

Other group

Description:

Women in reproductive age, without endometriosis, as control group for secondary objective 1 and 2.

Treatment:

Diagnostic Test: Fusobacterium detection