2015-Metabolomics&Microbiome-infertility

December 13, 2023 updated by: Andrea Salonia, IRCCS San Raffaele

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Furthermore, the study aims to assess if the blood and seminal alterations of infertile patients have similarities with the same fluids of elderly patients, validating from a metabolomic and microbiomic point of view the hypothesis of premature aging of infertile patients.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

  • 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)

Description

Inclusion 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)

Exclusion Criteria:

  • diagnosis of varicocele
  • endocrine alterations
  • chromosomal alterations
  • known genetic alterations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infertile men
Patients diagnosed with idiopathic non-obstructive azoospermia
Other: Analysis of microbiome and metabolomics
Analysis of microbiome and metabolomics through the assessment of blood and semen parameters
Fertile men
fertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria)
Other: Analysis of microbiome and metabolomics
Analysis of microbiome and metabolomics through the assessment of blood and semen parameters
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)
Other: Analysis of microbiome and metabolomics
Analysis of microbiome and metabolomics through the assessment of blood and semen parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic role of the blood and semen samples
Time Frame: Baseline
Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metabolomics&microbiome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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