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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02042352
First Posted: January 22, 2014
Last Update Posted: January 5, 2016
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.
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive
  Purpose

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 Intervention
Bacterial Vaginosis Other: pH glove

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Peter Humaidan, Regionshospitalet Viborg, Skive:

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

Biospecimen Retention:   Samples With DNA
Vaginal flora swabs

Enrollment: 195
Study Start Date: January 2014
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pH test
VpH test gloves
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.

  Eligibility

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Seeking IVF treatment

Exclusion Criteria:

  • Bleeding and sexual intercourse within 24h
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02042352


Locations
Denmark
The Fertility Clinic Skive
Skive, Denmark, 7800
Sponsors and Collaborators
Regionshospitalet Viborg, Skive
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Humaidan, Professor, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT02042352     History of Changes
Other Study ID Numbers: RSkive
First Submitted: January 16, 2014
First Posted: January 22, 2014
Last Update Posted: January 5, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis