Azoospermia, NonobstructiveNCT06181851
2015-Metabolomics&Microbiome-infertility
An observational study of Azoospermia, Nonobstructive, run by IRCCS San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Azoospermia, Nonobstructive
- What is being tested?
- Analysis of microbiome and metabolomics
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2016to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- diagnosis of varicocele
- endocrine alterations
- chromosomal alterations
- known genetic alterations
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Alessia d'Arma, PhD, 02 2643 5506, darma.alessia@hsr.it
About this study
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
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.
Read the 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.
- Conditions
- Azoospermia, Nonobstructive
- Being tested
- Analysis of microbiome and metabolomics
- Medical subject headings
- Azoospermia, Nonobstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of microbiome and metabolomicsOther
Analysis of microbiome and metabolomics through the assessment of blood and semen parameters
| Study group | Role | What they receive |
|---|---|---|
| Infertile men | Patients diagnosed with idiopathic non-obstructive azoospermia Receives: Other: Analysis of microbiome and metabolomics | |
| Fertile men | fertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria) Receives: Other: Analysis of microbiome and metabolomics | |
| 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) Receives: Other: Analysis of microbiome and metabolomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic role of the blood and semen samples
Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Jun 2016
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azoospermia, NonobstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Salonia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181851
- Sponsor's protocol ID
- Metabolomicsµbiome
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06181851
- Acronym / sponsor ID
- Metabolomicsµbiome
- Conditions
- Azoospermia, Nonobstructive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infertile men | – | Other: Analysis of microbiome and metabolomicsPatients diagnosed with idiopathic non-obstructive azoospermia |
| Fertile men | – | Other: Analysis of microbiome and metabolomicsfertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria) |
| Old fertile men | – | Other: Analysis of microbiome and metabolomicsSubjects known to have been fertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- diagnosis of varicocele
- endocrine alterations
- chromosomal alterations
- known genetic alterations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of microbiome and metabolomicsAnalysis of microbiome and metabolomics through the assessment of blood and semen parameters | Other | Fertile men, Infertile men, Old fertile men |
Primary outcome
Prognostic role of the blood and semen samples
Time frame: Baseline
Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Azoospermia, Nonobstructive, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Salonia, MD (02 2643 5661, salonia.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic role of the blood and semen samples (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.