Clinical trial NCT04784260: Microbiome Influence on Seminal Quality
Official title: Microbiome Influence on Seminal Quality on Semen Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Male
Keywords: Microbiome
Semen
Lead sponsor: Instituto Valenciano de Infertilidad, IVI Alicante
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seminal quality and microbiome
timeFrame: Two years
Secondary outcomes:
measure: Microbiome and individual semen quality parameters Microbiome as a fertility biomarker
timeFrame: seven months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: IVI Alicante
Study officials:
affiliation: Instituto Valenciano de Infertilidad, IVI Alicante
name: Elena Sellés, PhD
role: PRINCIPAL_INVESTIGATOR
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