Clinical trial NCT04641390: Interaction Between the Vaginal and Seminal Microbiome in Patients With an Altered Vaginal Microbiome Pattern Resistant to Treatment
Official title: Interaction Between the Vaginal and Seminal Microbiome in Patients With an Altered Vaginal Microbiome Pattern Resistant to Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fertility Disorders
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Participants with alteration of the vaginal microbiome resistant to drug treatment
timeFrame: 16 months
Secondary outcomes:
measure: Characteristics of the seminal microbiome of the participants whose partners with altered vaginal pattern responded well to drug treatment.
timeFrame: 16 months
measure: Characteristics of the seminal microbiome pattern in patients whose partners have been diagnosed with an altered vaginal microbiome resistant to drug treatment.
timeFrame: 16 months
measure: 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.
timeFrame: 16 months
Other outcomes:
Locations:
city: San Juan De Alicante
country: Spain
facility: University Miguel Hernández
state: Alicante
Study officials:
References: