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

Endometriosis Clinical Trial

— ENDS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368596
• Other study ID #: 2024-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: Elvia Malo
• Phone: +390456014854
• Email: ricerca.clinica[@]sacrocuore.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 845
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria di Negrar	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis		At surgical intervention
Secondary	Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis		At surgical intervention
Secondary	Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled		At preoperative visit
Secondary	Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis .		At surgical intervention
Secondary	Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present		At surgical intervention
Secondary	Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis		At surgical intervention
Secondary	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