Microbiome Influence on Seminal Quality

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Microbiome Influence on Seminal Quality on Semen Donors

Conditions
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Infertility, Male

Intervention / Treatment
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* Other: Microbiome analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A (normozoospermic): >15 mill/ml and >32% progressive mobility.<br>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. | Other: Microbiome analysis<br>* Evaluate the bacterial composition in sperm from the different groups<br>|
| Group B (normozoospérmic): <15 mill/ml and <32% progressive mobility.<br>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. | Other: Microbiome analysis<br>* Evaluate the bacterial composition in sperm from the different groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seminal quality and microbiome | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Semen