Microbiome Influence on Seminal Quality

Completed

• Conditions: Infertility, Male
• Interventions: Other: Microbiome analysis

• Registration Number: NCT04784260
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI Alicante

Brief Summary

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

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 Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Status Verified: 2022-02
• Primary Completion: 2023-01-12
• Study Completion: 2023-03-10
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A (normozoospermic): >15 mill/ml and >32% progressive mobility.	Microbiome analysis	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.
Group B (normozoospérmic): <15 mill/ml and <32% progressive mobility.	Microbiome analysis	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.

Primary Outcome Measures

Name	Time	Method
Seminal quality and microbiome	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.

Secondary Outcome Measures

Name	Time	Method
Microbiome and individual semen quality parameters Microbiome as a fertility biomarker	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.

Trial Locations

Locations (1)

IVI Alicante; 🇪🇸 Alicante, Spain