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Infertility, MaleNCT04784260

Microbiome Influence on Seminal Quality

An observational study of Infertility, Male, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Male
What is being tested?
Microbiome analysis
How many people
40 participants
Where
1 siteSpain
Study dates
1 Jun 2020to 10 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • IVI Alicante

    Alicante, 03015

Other trials in Spain

About this study

Official title: 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.

Read the 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.
Being tested
Microbiome analysis
Keywords
Microbiome, Semen
Medical subject headings
Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microbiome analysisOther

    Evaluate the bacterial composition in sperm from the different groups

Study groups in NCT04784260
Study groupRoleWhat they receive
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.
Receives: Other: Microbiome analysis
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.
Receives: Other: Microbiome analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Two years

Secondary outcomes (1)

  1. 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.

    Measured: seven months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start1 Jun 2020
  3. Primary completion12 Jan 2023
  4. Study completion10 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04784260
Sponsor's protocol ID
1911-ALC-100-ES
Status last verified
Feb 2022
First submitted
3 Mar 2021
Last updated
13 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rittenberg V, El-Toukhy T. Medical treatment of male infertility. Hum Fertil (Camb). 2010 Dec;13(4):208-16. doi: 10.3109/14647273.2010.534833.

    PubMed 21117930

  • Weng SL, Chiu CM, Lin FM, Huang WC, Liang C, Yang T, Yang TL, Liu CY, Wu WY, Chang YA, Chang TH, Huang HD. Bacterial communities in semen from men of infertile couples: metagenomic sequencing reveals relationships of seminal microbiota to semen quality. PLoS One. 2014 Oct 23;9(10):e110152. doi: 10.1371/journal.pone.0110152. eCollection 2014.

    PubMed 25340531

  • Marchesi JR, Ravel J. The vocabulary of microbiome research: a proposal. Microbiome. 2015 Jul 30;3:31. doi: 10.1186/s40168-015-0094-5. eCollection 2015.

    PubMed 26229597

  • Altmae S, Franasiak JM, Mandar R. The seminal microbiome in health and disease. Nat Rev Urol. 2019 Dec;16(12):703-721. doi: 10.1038/s41585-019-0250-y. Epub 2019 Nov 15.

    PubMed 31732723

  • Cox MJ, Cookson WO, Moffatt MF. Sequencing the human microbiome in health and disease. Hum Mol Genet. 2013 Oct 15;22(R1):R88-94. doi: 10.1093/hmg/ddt398. Epub 2013 Aug 13.

    PubMed 23943792

  • Koedooder R, Mackens S, Budding A, Fares D, Blockeel C, Laven J, Schoenmakers S. Identification and evaluation of the microbiome in the female and male reproductive tracts. Hum Reprod Update. 2019 May 1;25(3):298-325. doi: 10.1093/humupd/dmy048.

    PubMed 30938752

  • Monteiro C, Marques PI, Cavadas B, Damiao I, Almeida V, Barros N, Barros A, Carvalho F, Gomes S, Seixas S. Characterization of microbiota in male infertility cases uncovers differences in seminal hyperviscosity and oligoasthenoteratozoospermia possibly correlated with increased prevalence of infectious bacteria. Am J Reprod Immunol. 2018 Jun;79(6):e12838. doi: 10.1111/aji.12838. Epub 2018 Mar 3.

    PubMed 29500854

  • Gevers D, Knight R, Petrosino JF, Huang K, McGuire AL, Birren BW, Nelson KE, White O, Methe BA, Huttenhower C. The Human Microbiome Project: a community resource for the healthy human microbiome. PLoS Biol. 2012;10(8):e1001377. doi: 10.1371/journal.pbio.1001377. Epub 2012 Aug 14.

    PubMed 22904687

  • Hou D, Zhou X, Zhong X, Settles ML, Herring J, Wang L, Abdo Z, Forney LJ, Xu C. Microbiota of the seminal fluid from healthy and infertile men. Fertil Steril. 2013 Nov;100(5):1261-9. doi: 10.1016/j.fertnstert.2013.07.1991. Epub 2013 Aug 29.

    PubMed 23993888

  • Lloyd-Price J, Abu-Ali G, Huttenhower C. The healthy human microbiome. Genome Med. 2016 Apr 27;8(1):51. doi: 10.1186/s13073-016-0307-y.

    PubMed 27122046

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility, Male, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seminal quality and microbiome (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04784260, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.

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