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

Fertility Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04641390
• Other study ID #: InstitutoBernabeu2
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: August 2021
• Source: Instituto Bernabeu
• Contact: RAUF NOUNI, DR
• Phone: 677029706
• Email: raufrng[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 15, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	University Miguel Hernández	San Juan De Alicante	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with alteration of the vaginal microbiome resistant to drug treatment		16 months
Secondary	Characteristics of the seminal microbiome of the participants whose partners with altered vaginal pattern responded well to drug treatment.		16 months
Secondary	Characteristics of the seminal microbiome pattern in patients whose partners have been diagnosed with an altered vaginal microbiome resistant to drug treatment.		16 months
Secondary	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