Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy

NCT06414720 | Recruiting DMC

• 1 other identifier: ENDOmiRNA
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Keywords

Endometriosis; miRNA; Progesterone resistance

Outcome Measures

Primary Outcomes (3)

• 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

  0 (pre-therapy) - 4 months (after therapy)

• changes in quality of life

  changes in quality of life assessed with questionnaire SF-36 (Short Form Health Survey 36)

  0 (pre-therapy) - 4 months (after therapy)

• 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.

  sample collection at time 0, analysis after time 4

Study Arms (1)

Endometriosis patients

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.

Drug: Dienogest 2 MG

Interventions

Dienogest 2 MG DRUG

The patients will be started on progestin therapy after a saliva sample is collected from them for miRNA analysis.

Also known as: zafrilla, devicius, endodien, visanne

Endometriosis patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Udine: lead

Study Sites (1)

University of Udine

Udine, UD, 33100, Italy

RECRUITING

Related Publications (3)

• Bendifallah S, Suisse S, Puchar A, Delbos L, Poilblanc M, Descamps P, Golfier F, Jornea L, Bouteiller D, Touboul C, Dabi Y, Darai E. Salivary MicroRNA Signature for Diagnosis of Endometriosis. J Clin Med. 2022 Jan 26;11(3):612. doi: 10.3390/jcm11030612.

  PMID: 35160066 BACKGROUND

• Zhang P, Wang G. Progesterone Resistance in Endometriosis: Current Evidence and Putative Mechanisms. Int J Mol Sci. 2023 Apr 10;24(8):6992. doi: 10.3390/ijms24086992.

  PMID: 37108154 BACKGROUND

• Hon JX, Wahab NA, Karim AKA, Mokhtar NM, Mokhtar MH. MicroRNAs in Endometriosis: Insights into Inflammation and Progesterone Resistance. Int J Mol Sci. 2023 Oct 9;24(19):15001. doi: 10.3390/ijms241915001.

  PMID: 37834449 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

salivary specimen

MeSH Terms

Conditions

Endometriosis; Progesterone Resistance

Interventions

dienogest

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Giuseppe Vizzielli, prof

  University of Udine

  STUDY CHAIR

Central Study Contacts

Matilde Degano, dr

CONTACT

3206173076; matildedegano@rocketmail.com

Anna Biasioli, dr

CONTACT

anna.biasioli@asufc.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 16, 2024
• Study Start: April 22, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

IT (1)