PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting
NCT ID: NCT02042352
Last Updated: 2016-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
195 participants
OBSERVATIONAL
2014-01-31
2015-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pH test
VpH test gloves
pH glove
Interventions
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pH glove
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
42 Years
FEMALE
Yes
Sponsors
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Regionshospitalet Viborg, Skive
OTHER
Responsible Party
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Peter Humaidan
Professor
Locations
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The Fertility Clinic Skive
Skive, , Denmark
Countries
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References
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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.
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.
Haahr 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.
Other Identifiers
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RSkive
Identifier Type: -
Identifier Source: org_study_id
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