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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02042352
Enrollment
195
Registered
2014-01-22
Start date
2014-01-31
Completion date
2015-02-28
Last updated
2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis

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.

Interventions

OTHERpH glove

Sponsors

Regionshospitalet Viborg, Skive
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

Inclusion criteria

* Seeking IVF treatment

Exclusion criteria

* Bleeding and sexual intercourse within 24h

Design outcomes

Primary

MeasureTime frame
Cost-benefit analysis of the molecular tests to conventional Gram staining1 year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026