Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT07078435
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18-42 years.
* Surgery scheduled during the luteal phase.
* Written informed consent provided.
Additional inclusion criteria for the "endometriosis" group:
* Women with confirmed endometriosis and a surgical indication (due to persistent symptoms despite medical treatment and/or risk of organ damage).
* Hormonal therapy discontinued at least one month prior to surgery.
* Absence of isolated ovarian endometrioma.
Control group inclusion criteria:
\- Women requiring benign gynecological surgery with no clinical or intraoperative evidence of endometriosis.
No inclusion criteria (both groups):
* Presence of inflammatory bowel disease (Crohn's disease, ulcerative colitis) or other autoimmune disorders (e.g., lupus, Sjögren's syndrome, antiphospholipid syndrome, rheumatoid arthritis, spondyloarthritis),
* Use of antibiotics within the month prior to surgery,
* Recent infection (\<2 weeks),
* Ongoing treatment with biologics or immunosuppressants,
* Contraindication to surgery due to general condition or comorbidities,
* Hormonal therapy within the month prior to surgery,
* Abdominopelvic surgery involving peritoneal breach within the previous 6 months,
* Pregnancy or breastfeeding,
* Participation in another clinical study (RIPH 1 or 2).
Exclusion Criteria:
* Intraoperative impossibility to perform surgery due to local conditions with an unfavorable benefit-risk balance for the patient.
* Discovery of endometriosis during surgery in the control group.
* Use of biologics or immunosuppressants within the first year after inclusion in the endometriosis group.
* Antibiotic use in the month preceding the second stool sample (endometriosis group).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
42 Years
Study:
NCT07078435
Study Brief:
Protocol Section:
NCT07078435