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

NCT04641390 | Unknown DMC

• 1 other identifier: InstitutoBernabeu2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Disorders

Outcome Measures

Primary Outcomes (1)

• Participants with alteration of the vaginal microbiome resistant to drug treatment

  16 months

Secondary Outcomes (3)

• 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

Study Arms (3)

Casos

altered vaginal microbiome resistant to drug treatment

Other: Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment

Controles

Altered vaginal microbiome not resistant to drug treatment

Other: Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment

semen donors

The semen donors included in the present work will be men between 18 and 35 years old who are included in the donation program of Instituto Bernabeu after having passed a series of physical, psychological, analytical, genetic and serological evaluations and are considered suitable for donation as established by Royal Decree-Law 9/2014. Likewise, donors are subjected to a series of seminal quality evaluations and seminal freeze-thaw tests in order to guarantee their fertile potential. In this way, the donors who are part of the Instituto Bernabeu donation program also comply with current legal regulations with a strict evaluation to be considered the gold standard of potentially fertile semen. In addition, it will be necessary for them to provide a signed informed consent accepting their participation in the study.

Interventions

Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment OTHER

The analysis of the seminal microbiome will be carried out by massive genetic sequencing

Casos

Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment OTHER

The analysis of the seminal microbiome will be carried out by massive genetic sequencing

Controles

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be patients whose partners have a diagnosis of an altered vaginal microbiome with persistence of drug treatment or without persistence of drug treatment.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Bernabeu: lead

Study Sites (1)

University Miguel Hernández

Sant Joan d'Alacant, Alicante, 03550, Spain

RECRUITING

Central Study Contacts

RAUF NOUNI, DR

CONTACT

677029706; raufrng@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory service manager

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: November 23, 2020
• Study Start: February 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: April 15, 2022
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

ES (1)