Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2020-06-01
2023-03-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Microbiome analysis
Evaluate the bacterial composition in sperm from the different groups
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.
Microbiome analysis
Evaluate the bacterial composition in sperm from the different groups
Interventions
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Microbiome analysis
Evaluate the bacterial composition in sperm from the different groups
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
35 Years
MALE
Yes
Sponsors
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Instituto Valenciano de Infertilidad, IVI Alicante
OTHER
Responsible Party
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Principal Investigators
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Elena Sellés, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Valenciano de Infertilidad, IVI Alicante
Locations
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IVI Alicante
Alicante, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1911-ALC-100-ES
Identifier Type: -
Identifier Source: org_study_id
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