Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy (ENDOmiRNA)

University of Udine

Status: Enrolling

Conditions: Endometriosis

Treatments: Drug: Dienogest 2 MG

Study type: Observational

Funder types: Other

Identifiers

NCT06414720

ENDOmiRNA

Details and patient eligibility

About

This study aims to analyze the salivary miRNA specific for patients diagnosed with endometriosis, specifically evaluating the miRNA profile of patients who respond versus those who do not respond to progestin therapy. Ninety patients attending the Chronic Pelvic Pain Clinic will be recruited, and they will be asked to provide a saliva sample before starting medical therapy. The response to the therapy will be evaluated after 4 months from the beginning of the therapy itself.

Full description

In recent years, scientific literature has focused on the search for new non-invasive diagnostic tools that can identify patients with endometriosis early and easily, thereby reducing diagnostic delay and enabling the immediate initiation of appropriate treatment. Among these, microRNA (miRNA) is emerging as a promising option. Despite recent progress in this field, a predictive biomarker of response to medical therapy or vice versa, resistance to progesterone in endometriosis, has not yet been identified, including among miRNAs. This study aims, therefore, to identify salivary miRNA signatures specific to endometriosis and differentially expressed between responder and non-responder patients to 2 mg dienogest medical therapy. 90 patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine will be enrolled. The investigators will ask them for a salivary sample before starting the progestin therapy. After 4 months from the beginning, the response will be evaluated. The researchers will evaluate the differences between salivary miRNA of the responders vs non-responders.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

• Age > 18 years
• Fertile age
• Clinical-ultrasound diagnosis or histological diagnosis of endometriosis
• Informed consent

EXCLUSION CRITERIA

• Pregnancy
• Pre-menarcheal or post-menopausal status
• Chronic pelvic pain syndrome with or without central sensitization assessed with the Central Sensitization Inventory Test (CSI)
• Neoplasia, diabetes, BMI > 30 kg/m2, coagulopathies, autoimmune diseases, or other conditions that may affect salivary miRNA measurement
• Currently undergoing progestin therapy

Trial design

90 participants in 1 patient group

Endometriosis patients

Description:

Patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who have not yet started medical therapy.

Treatment:

Drug: Dienogest 2 MG