2015-Metabolomics&Microbiome-infertility
- Conditions
- Azoospermia, Nonobstructive
- Interventions
- Other: Analysis of microbiome and metabolomics
- Registration Number
- NCT06181851
- Lead Sponsor
- IRCCS San Raffaele
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 45
- 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)
- diagnosis of varicocele
- endocrine alterations
- chromosomal alterations
- known genetic alterations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Infertile men Analysis of microbiome and metabolomics Patients diagnosed with idiopathic non-obstructive azoospermia Fertile men Analysis of microbiome and metabolomics fertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria) Old fertile men Analysis of microbiome and metabolomics 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)
- Primary Outcome Measures
Name Time Method Prognostic role of the blood and semen samples Baseline Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IRCCS Ospedale San Raffaele
🇮🇹Milan, Lombardy, Italy