Microbiome Influence on Seminal Quality

Microbiome Influence on Seminal Quality on Semen Donors

The microbiome plays an important role in health and in some unknown etiologies. Some previous studies have identified bacteria in semen as a potential factor in male infertility. More studies are needed to discover associations between microbiomes and semen quality. In this study, forty semen samples from donors candidates will be collected where clinical criteria for seminal quality (volume, concentration, motility and morphology) will be measured and bacterial communities examined. With the next-generation sequencing of gene technology and bioinformatic analysis, we can investigate the associations between bacterial communities and seminal quality. It would be interesting to know if the proportion of certain bacteria is significantly higher in samples of normal seminal quality or significantly higher in samples of low seminal quality. This study could contribute to the current understanding of certain etiologies of male fertility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surplus semen samples will be collected from donor candidates who come to the IVI Alicante clinic with ages between 18 and 35 years old and who intend to participate in the donation program for the semen bank, and come to evaluate their quality. Informed consent for this study will be given to all of them, which they will have to return signed.

Depending on the semen quality evaluated in the diagnostic sample within the usual practice, in the laboratory the participants will be divided into 2 groups according to the WHO reference values in terms of sperm concentration and percentage of progressive motility:

  • Group A (Normozoospermics): ≥15 mill / ml and> 32% progressive mobility.
  • Group B (Non-normozoospermic): <15 mill / ml and <32% progressive mobility. The study will consist of 2 years. The first year will be used to collect all the diagnostic seminal samples from donor candidates, and the second year will be used in its first months to analyze the microbiome by extracting DNA from ejaculates, amplifying bacterial DNA with targeted primers. to the bacterial 16S rRNA gene regions, sequencing, library preparation and bioinformatic analysis.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Alicante, Spain, 03015
        • IVI Alicante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study will include those donor candidates who come to undergo the diagnostic spermiogram within the usual practice and who have previously undergone an informative visit about the donation program and have been accepted for their profile and anamnesis regarding their family history and of health.

Description

Inclusion Criteria:

  • 18-35 years. Suitable on your first informational visit.

Exclusion Criteria:

  • Presence of own or hereditary pathology. Presence of mental or behavioral disturbance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A (normozoospermic): >15 mill/ml and >32% progressive mobility.
Analysis of the microbiome by extracting DNA from ejaculates, amplification of bacterial DNA with feeders aimed at the regions of the bacterial rRNA 16 S gene, sequencing, library preparation and bioinformatic analysis.
Evaluate the bacterial composition in sperm from the different groups
Group B (normozoospérmic): <15 mill/ml and <32% progressive mobility.
Analysis of the microbiome by extracting DNA from ejaculates, amplification of bacterial DNA with feeders aimed at the regions of the bacterial rRNA 16 S gene, sequencing,library preparation and bioinformatic analysis.
Evaluate the bacterial composition in sperm from the different groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seminal quality and microbiome
Time Frame: Two years
Evaluate the bacterial composition of semen in a given population (sperm donor) analyzing the microbiome by extracting DNA from ejaculates, amplifying bacterial DNA with targeted primers to the bacterial 16S rRNA gene regions, sequencing, library preparation and bioinformatic analysis.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome and individual semen quality parameters Microbiome as a fertility biomarker
Time Frame: seven months
To assess whether the composition of the microbiome affects the different seminal quality parameters studied differently (concentration, mobility,...) It would be interesting with these findings to study the possibility of finding biomarkers that indicate that the presence of certain microorganisms may negatively or positively affect seminal quality and, that either by the presence or absence of these, they can help us to find a relationship with the seminal parameters studied, in order to find a cause and a possible treatment that can improve. In addition, see if it would help improve the diagnosis of infertility cases where there is no other apparent cause.
seven months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

January 12, 2023

Study Completion (Actual)

March 10, 2023

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1911-ALC-100-ES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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