NCT04784260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2023

Completed
Last Updated

March 13, 2023

Status Verified

February 1, 2022

Enrollment Period

2.6 years

First QC Date

March 3, 2021

Last Update Submit

March 10, 2023

Conditions

Infertility, Male

Keywords

MicrobiomeSemen

Outcome Measures

Primary Outcomes (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.

    Two years

Secondary Outcomes (1)

  • Microbiome and individual semen quality parameters Microbiome as a fertility biomarker

    seven months

Study Arms (2)

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.

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.

Other: Microbiome analysis

Interventions

Microbiome analysisOTHER

Evaluate the bacterial composition in sperm from the different groups

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

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • years. Suitable on your first informational visit.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Alicante

Alicante, 03015, Spain

Location

Related Publications (10)

  • 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.

    PMID: 21117930BACKGROUND

  • 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.

    PMID: 25340531BACKGROUND

  • 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.

    PMID: 26229597BACKGROUND

  • 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.

    PMID: 31732723BACKGROUND

  • 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.

    PMID: 23943792BACKGROUND

  • 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.

    PMID: 30938752BACKGROUND

  • 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.

    PMID: 29500854BACKGROUND

  • 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.

    PMID: 22904687BACKGROUND

  • 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.

    PMID: 23993888BACKGROUND

  • 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.

    PMID: 27122046BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Elena Sellés, PhD

    Instituto Valenciano de Infertilidad, IVI Alicante

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

June 1, 2020

Primary Completion

January 12, 2023

Study Completion

March 10, 2023

Last Updated

March 13, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)