PNA FISH, PCR and Gram Staining for Detection of Bacteria... | NCT02042352

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

NCT02042352

Sponsor

Regionshospitalet Viborg, Skive

Status

Completed

Last Update Posted

Jan 5, 2016Estimated

Enrollment

195Actual

Phase

Not provided

Conditions

Bacterial Vaginosis

Interventions

pH glove

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jan 16, 2014

First Submission Date that Met QC Criteria

Jan 19, 2014

First Posted Date

Jan 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2016

Last Update Posted Date

Jan 5, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Humaidan, Professor, Regionshospitalet Viborg, SkivePrincipal Investigator

Lead Sponsor

Regionshospitalet Viborg, SkiveOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

195Actual

Label	Type	Description	Intervention Names
pH test		VpH test gloves	Other: pH glove

Name	Type	Description	Arm Group Labels	Other Names
pH glove	Other		pH test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cost-benefit analysis of the molecular tests to conventional Gram staining		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Seeking IVF treatment

Exclusion Criteria:

Bleeding and sexual intercourse within 24h

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

IVF patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Fertility Clinic Skive		Skive		7800	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33050261	Derived	Jakobsen RR, Haahr T, Humaidan P, Jensen JS, Kot WP, Castro-Mejia JL, Deng L, Leser TD, Nielsen DS. Characterization of the Vaginal DNA Virome in Health and Dysbiosis. Viruses. 2020 Oct 9;12(10):1143. doi: 10.3390/v12101143.
30597027	Derived	Haahr T, Humaidan P, Elbaek HO, Alsbjerg B, Laursen RJ, Rygaard K, Johannesen TB, Andersen PS, Ng KL, Jensen JS. Vaginal Microbiota and In Vitro Fertilization Outcomes: Development of a Simple Diagnostic Tool to Predict Patients at Risk of a Poor Reproductive Outcome. J Infect Dis. 2019 May 5;219(11):1809-1817. doi: 10.1093/infdis/jiy744.

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis