Fertility Disorders
Conditions
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.
Interventions
OTHERAnalysis 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
OTHERAnalysis 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
Sponsors
Instituto Bernabeu
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants with alteration of the vaginal microbiome resistant to drug treatment | 16 months |
Secondary
| 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 |
Countries
Spain
Contacts
Primary ContactRAUF NOUNI, DR
Outcome results
None listed