PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting
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|ClinicalTrials.gov Identifier: NCT02042352|
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : January 5, 2016
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.
|Condition or disease||Intervention/treatment|
|Bacterial Vaginosis||Other: pH glove|
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 Type :||Observational|
|Actual Enrollment :||195 participants|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
VpH test gloves
|Other: pH glove|
- Cost-benefit analysis of the molecular tests to conventional Gram staining [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042352
|The Fertility Clinic Skive|
|Skive, Denmark, 7800|