PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting
1 other identifier
observational
195
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 16, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJanuary 5, 2016
January 1, 2016
1.1 years
January 16, 2014
January 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Cost-benefit analysis of the molecular tests to conventional Gram staining
1 year
Study Arms (1)
pH test
VpH test gloves
Interventions
Eligibility Criteria
IVF patients
You may qualify if:
- Seeking IVF treatment
You may not qualify if:
- Bleeding and sexual intercourse within 24h
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fertility Clinic Skive
Skive, 7800, Denmark
Related Publications (3)
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.
PMID: 33050261DERIVEDHaahr 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.
PMID: 30597027DERIVEDHaahr T, Jensen JS, Thomsen L, Duus L, Rygaard K, Humaidan P. Abnormal vaginal microbiota may be associated with poor reproductive outcomes: a prospective study in IVF patients. Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23.
PMID: 26911864DERIVED
Biospecimen
Vaginal flora swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 16, 2014
First Posted
January 22, 2014
Study Start
January 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
January 5, 2016
Record last verified: 2016-01