Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy
ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Udine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Fertile age
Clinical-ultrasound diagnosis or histological diagnosis of endometriosis
Informed consent
Disqualifiers
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
Trial population
All the patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who meet the inclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dienogest 2 MG
DrugThe patients will be started on progestin therapy after a saliva sample is collected from them for miRNA analysis.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Endometriosis patients1 intervention
Trial outcomes
Primary outcomes
1
response to the progestin therapy
response to 2 mg dienogest therapy evaluated with NRS (numeric rating scale) scale assessed for acyclic pain, dyspareunia, dyschezia, dysmenorrhea, periovulatory pain
Time frame
0 (pre-therapy) - 4 months (after therapy)2
changes in quality of life
changes in quality of life assessed with questionnaire SF-36 (Short Form Health Survey 36)
Time frame
0 (pre-therapy) - 4 months (after therapy)3
differences in salivary miRNoma
Once it is established which patients are responders and which are non-responders, differential salivary miRNAs between the two groups will be identified via sequencing. The miRNA reverse transcription reaction will be performed using the reverse transcription kit TaqMan MicroRNA (Applied Biosystems). The reverse transcription product will be used for Real-time PCR. The small nucleolar RNA RNU6 will be used as an endogenous control. The protocol of Amplification will be carried out using the LightCycler 480 instrument (Roche). For each miRNA, qPCR will be performed in duplicate. The relative expression levels of miRNAs will be calculated using the 2-ΔΔCt method.
Time frame
sample collection at time 0, analysis after time 4Sponsors and contacts
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Source ClinicalTrials.gov