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

Regionshospitalet Viborg, Skive

Status

Completed

Conditions

Bacterial Vaginosis

Treatments

Other: pH glove

Study type

Observational

Funder types

Other

Identifiers

NCT02042352

RSkive

Details and patient eligibility

About

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.

Full 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.

Enrollment

195 patients

Sex

Female

Ages

18 to 42 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria