Search for Genetic Basis of Vulvodynia

Completed

• Conditions: Vulvodynia

• Registration Number: NCT01664962
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief Summary

The purpose of this study is to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Detailed Description

The short-term goal proposed for the current study was to investigate the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Eight polymorphic SNPs in the three different genes suspected to be involved in LPV has been examined as follow:

1. HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that were found to be informative in the Ashkenazi Jewish population

2. TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080.

3. NGF gene: A novel T to C SNP in the promoter region at position -198 (rs11102930) and rs6330 which was found to be associated with anxiety-related personality traits and has been suggested to may affect intracellular processing and secretion of NGF.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Status Verified: 2012-08
• Study First Submitted: 2012-08-09
• Study First Submitted QC: 2012-08-13
• Last Update Submitted: 2012-08-13
• Study First Posted: 2012-08-14
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

o meeting Friedrich's criteria [50] for vulva vestibulitis syndrome

• diagnosed by a gynecological examination with LPV
• diagnosed with a severe degree of the syndrome according to Marinoff [48]
• classified with the primary type of the syndrome according to an interview
• with both parents of Ashkenazi origin.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic association of Vulvodynia	four years	the possibility of an association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

Trial Locations

Locations (1)

Western Galilee Hospital; 🇮🇱 Nahariya, Israel