2015-Metabolomics&Microbiome-infertility
Microbiome and Metabolomics Analysis in a Population of Infertile Patients Suffering From Non-obstructive Azospermia and Examination of Their Impact on the Reproductive Potential and Global Health of the Individual
1 other identifier
observational
45
1 country
1
Brief Summary
The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 13, 2023
CompletedFirst Posted
Study publicly available on registry
December 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
December 26, 2023
December 1, 2023
10 years
December 13, 2023
December 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Prognostic role of the blood and semen samples
Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa
Baseline
Study Arms (3)
Infertile men
Patients diagnosed with idiopathic non-obstructive azoospermia
Fertile men
fertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria)
Old fertile men
Subjects known to have been fertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria)
Interventions
Analysis of microbiome and metabolomics through the assessment of blood and semen parameters
Eligibility Criteria
* diagnosis of idiopathic non-obstructive azoospermia * fertile men (pregnancy within 12 months from the start of the couple's search) * men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching)
You may qualify if:
- diagnosis of idiopathic non-obstructive azoospermia
- fertile men (pregnancy within 12 months from the start of the couple's search)
- men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching)
You may not qualify if:
- diagnosis of varicocele
- endocrine alterations
- chromosomal alterations
- known genetic alterations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 13, 2023
First Posted
December 26, 2023
Study Start
June 1, 2016
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
December 26, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share