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

• Conditions: Fertility Disorders

• Registration Number: NCT04641390
• Lead Sponsor: Instituto Bernabeu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-23
• Study Start: 2021-02-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30
• Primary Completion: 2021-12-15
• Study Completion: 2022-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Woman who has an altered vaginal microbiome when the presence of bacteria of the Lactobacillus genus is less than 90% and / or the presence of bacteria that cause bacterial vaginosis (Pj: Gardnerella) or that make embryo implantation difficult in a percentage is determined greater than 5%
• Males will be between 18 and 50 years old
• Signed informed consent accepting their participation in the study.
• Male donors will be between 18 and 35 years old

Exclusion Criteria

• Men who present with fever
• Men who are under treatment with antibiotics
• Men who have an active sexually transmitted disease
• Men who have a chronic prostatitis or a urinary infection (such as epididymitis or orchitis).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants with alteration of the vaginal microbiome resistant to drug treatment	16 months

Secondary Outcome Measures

Name	Time	Method
Characteristics of the seminal microbiome of the participants whose partners with altered vaginal pattern responded well to drug treatment.	16 months
Characteristics of the seminal microbiome pattern in patients whose partners have been diagnosed with an altered vaginal microbiome resistant to drug treatment.	16 months
Semen donor participants eligible for donation as established by Royal Decree-Law 9/2014 to establish a seminal microbiome pattern considered optimal to compare it with participants with an altered seminal microbioma pattern.	16 months

Trial Locations

Locations (1)

University Miguel Hernández; 🇪🇸 San Juan De Alicante, Alicante, Spain