2015-Metabolomics&Microbiome-infertility

Azoospermia, Nonobstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181851
• Other study ID #: Metabolomics&microbiome
• Status: Recruiting
• Start date: June 1, 2016
• Est. completion date: May 31, 2026

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: Andrea Salonia, MD
• Phone: 02 2643 5661
• Email: salonia.andrea[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Azoospermia
• Azoospermia, Nonobstructive

Intervention

Other:
• Analysis of microbiome and metabolomics
Analysis of microbiome and metabolomics through the assessment of blood and semen parameters

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic role of the blood and semen samples	Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa	Baseline