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

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.

Study Overview

• Status: Recruiting
• Conditions: Fertility Disorders
• Intervention / Treatment: Other: Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment; Other: Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: RAUF NOUNI, DR; Phone Number: 677029706; Email: raufrng@gmail.com

Study Locations

• Spain
  • Alicante
    • San Juan De Alicante, Alicante, Spain, 03550
      • Recruiting
      • University Miguel Hernandez
      • Contact: RAUF N Nouni, DR; Phone Number: 677029706; Email: raufrng@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The analysis of the seminal microbiome will be carried out by massive genetic sequencing
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; The analysis of the seminal microbiome will be carried out by massive genetic sequencing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participants with alteration of the vaginal microbiome resistant to drug treatment	16 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto Bernabeu

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): December 15, 2021
• Study Completion (ANTICIPATED): April 15, 2022

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (ACTUAL): November 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: InstitutoBernabeu2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No