Actively Recruiting
Vestibulodynia At High Resolution: Omics Approach to Improve Diagnosis
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-03-10
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Vestibulodynia (VBD) is a common form of vulvodynia characterized by vulvar pain without a clear cause, lasting at least three months. It mainly affects sexually active women of reproductive age and is often underdiagnosed due to the absence of clear markers and sociocultural factors. Researchers are studying the disease's molecular markers and underlying mechanisms to improve diagnosis and treatment, aiming to identify specific markers through advanced genetic analysis. This observational study collects specimens such as vulvar biopsies and blood samples from women diagnosed with VBD and healthy controls. The study uses transcriptomic and single-cell omics analyses to discover molecular markers related to VBD. It aims to stratify patient groups based on these markers, helping future personalized medicine approaches. Participants will provide samples and undergo assessments over 12 months, during which molecular markers at the mRNA and protein levels will be measured. The study involves women aged 18 to 50, with certain exclusions to ensure accurate results. The research will help clinicians diagnose VBD earlier, guide therapies, and identify patients at risk of developing chronic symptoms.
CONDITIONS
Brief Title
Vestibulodynia At High Resolution: Omics Approach to Improve Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50
- Abstinence from intercourse for 7 days prior to the visit
- No use of intravaginal products for 7 days prior to the visit
You will not qualify if you...
- Generalized vulvodynia or only spontaneous vestibulodynia without provoked pain
- Endometriosis
- Pregnancy
- Infectious vulvar disease
- Post-menopause
- Breastfeeding
- Gave birth within the last 4 months
- Use of systemic or vaginal antimicrobial or probiotic therapy within 1 month before the visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants provide vulvar biopsy and blood samples for molecular analysis.
1 to 2 visits depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
B
Barbara Gardella, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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