NCT04641390

Interaction Between the Vaginal and Seminal Microbiome in Patients With an Altered Vaginal Microbiome Pattern Resistant to Treatment

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Instituto Bernabeu · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

It,s a retrospective case-control pilot study is to be carried out. Twenty patients will be included in the study for each branch (a total of 60). The study population will be patients whose partners have a diagnosis of an altered vaginal microbiome with (Cases, n = 20) or without (Controls, n = 20) persistence to drug treatment. Since a normal reference seminal microbiome has not been described, we will include a control group that will consist of sperm donors (n = 20) who are considered fertile potential without reproductive problems. The main objective of the project is to identify the interaction of the vaginal and seminal microbiome patterns in couples in which the vaginal pattern is altered and is persistent to drug treatment.

Conditions

• Fertility Disorders

Interventions

Type	Name	Description
OTHER	Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment	The analysis of the seminal microbiome will be carried out by massive genetic sequencing
OTHER	Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment	The analysis of the seminal microbiome will be carried out by massive genetic sequencing

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-12-15
• Completion: 2022-04-15
• First posted: 2020-11-23
• Last updated: 2021-08-30

Locations

1 site across 1 country: Spain