PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Other: pH glove

• Registration Number: NCT02042352
• Lead Sponsor: Regionshospitalet Viborg, Skive

Brief Summary

The primary aim of the present study is to investigate the vaginal microbiota of infertile women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and a PCR method supported with conventional Gram staining.

We hypothesize that the molecular based tests will prove more efficient than conventional Gram staining and that they have a place in future IVF diagnostics.

Detailed Description

Our first aim is to investigate the prevalence of altered vaginal microbiotas among women seeking fertility treatment in Denmark. Secondly we want to establish whether there are correlations between altered vaginal microbiotas and self-measurements of both the vaginal pH performed with the Saling pH glove™ and a self-collected swab with Copan Eswab™ because these would be useful for an easy-access longitudinal screening option. Finally, the third aim was to explore how the species composition of vaginal microbiotas measured by a multiplex qPCR assay was reflected in Nugent scores.

A possible 4th aim is to identify patterns in the relative abundances of different species with 16sRNA primers among fertile women compared with infertile women because these differences could be indicative of a vaginal microbiota associated with bad fertility outcome.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-19
• Study First Posted: 2014-01-22
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-01
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 195

Inclusion Criteria

• Seeking IVF treatment

Exclusion Criteria

• Bleeding and sexual intercourse within 24h

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pH test	pH glove	VpH test gloves

Primary Outcome Measures

Name	Time	Method
Cost-benefit analysis of the molecular tests to conventional Gram staining	1 year

Trial Locations

Locations (1)

The Fertility Clinic Skive; 🇩🇰 Skive, Denmark