Search for Genetic Basis of Vulvodynia

NCT ID: NCT01664962

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Vulvodynia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

Women with severe Vulvodynia

No interventions assigned to this group

Healthy controls

Women without vulvodynia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Jacob Bornstein

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Western Galilee Hospital

Nahariya, , Israel

Site Status

Countries

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Israel

Other Identifiers

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920080002

Identifier Type: -

Identifier Source: org_study_id