NCT03420859

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,850 (estimated)
• Sponsor: Peter Humaidan · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Abnormal Vaginal Microbiota
• Infertility

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	qPCR for abnormal vaginal microbiota	qPCR for A.vaginae and/or G.vaginalis as developed in the pilot study (Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23.)

Timeline

• Start date: 2017-12-04
• Primary completion: 2023-08-08
• Completion: 2024-01-01
• First posted: 2018-02-05
• Last updated: 2023-04-27

Locations

1 site across 1 country: Denmark