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The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes

Infertility Clinical Trial

Official title:
The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes

Clinical Trial Summary

A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT (EUDRACT 2016-002385-31). Secondary aims are the prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene and relations to the vaginal microbiota, basic fertility work up in relation to vaginal microbiota.

Clinical Trial Description

At the time of the interim stage of the RCT (EUDRACT 2016-002385-31), we plan to make a first cross-sectional investigation of the intimate hygiene questionnaire at baseline as compared to abnormal vaginal microbiota. We plan to make focused interview of N=30 patients to cover any additional female hygiene details not covered in the original questionnaire. After this investigation we may include new questions after the interim analysis - given that the study proceeds. In this case we plan to publish the first results of the intimate hygiene habits of the patients enrolled until interim stage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03420859
Study type Observational
Source Regionshospitalet Viborg, Skive
Contact
Status Active, not recruiting
Phase
Start date December 4, 2017
Completion date January 1, 2024
View Details
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