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

Instituto Bernabeu

Status: Unknown

Conditions: Fertility Disorders

Treatments: 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

Funder types: Other

Identifiers

NCT04641390

InstitutoBernabeu2

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

20 participants in 3 patient groups

Casos

Description:

altered vaginal microbiome resistant to drug treatment

Treatment:

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

Controles

Description:

Altered vaginal microbiome not resistant to drug treatment

Treatment:

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

semen donors

Description:

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.