Microbiome Influence on Seminal Quality

Infertility, Male Clinical Trial

Official title:

Microbiome Influence on Seminal Quality on Semen Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784260
• Other study ID #: 1911-ALC-100-ES
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: March 10, 2023

Study information

• Verified date: February 2022
• Source: Instituto Valenciano de Infertilidad, IVI Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 10, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Other:
• Microbiome analysis
Evaluate the bacterial composition in sperm from the different groups

Locations

Country	Name	City	State
Spain	IVI Alicante	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI Alicante

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	seven months