Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02042352
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : January 5, 2016
Information provided by (Responsible Party):
Peter Humaidan, 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.

Condition or disease Intervention/treatment
Bacterial Vaginosis Other: pH glove

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Group/Cohort Intervention/treatment
pH test
VpH test gloves
Other: pH glove

Primary Outcome Measures :
  1. Cost-benefit analysis of the molecular tests to conventional Gram staining [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Vaginal flora swabs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
IVF patients

Inclusion Criteria:

  • Seeking IVF treatment

Exclusion Criteria:

  • Bleeding and sexual intercourse within 24h

Information from the National Library of Medicine

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 identifier (NCT number): NCT02042352

Layout table for location information
The Fertility Clinic Skive
Skive, Denmark, 7800
Sponsors and Collaborators
Regionshospitalet Viborg, Skive

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Peter Humaidan, Professor, Regionshospitalet Viborg, Skive Identifier: NCT02042352     History of Changes
Other Study ID Numbers: RSkive
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections