ClinicalTrials.gg
RecruitingNCT06181851Updated Dec 26, 2023

2015-Metabolomics&Microbiome-infertility

An observational study in Azoospermia, Nonobstructive, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2016; still recruiting 10 years 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
45
Ages
18 Years to 75 Years
Sex
Male
01

Study 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.

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.

02

Conditions studied

  • Azoospermia, Nonobstructive
03

In context

Azoospermia, Nonobstructive

23 studies on the registry are indexed under Azoospermia, Nonobstructive; 7 are open to participants now.

This study's planned enrollment of 45 is below the median of 94 across 10 observational studies indexed under Azoospermia, Nonobstructive.

Browse Azoospermia, Nonobstructive studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • diagnosis of varicocele
  • endocrine alterations
  • chromosomal alterations
  • known genetic alterations
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
45 participants (estimated)
Patient registry
No

Groups and cohorts

  • Infertile men

    Patients diagnosed with idiopathic non-obstructive azoospermia

    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)

    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)

    Other: Analysis of microbiome and metabolomics

Interventions

  • OtherAnalysis of microbiome and metabolomics

    Analysis of microbiome and metabolomics through the assessment of blood and semen parameters

06

What researchers measure

Primary outcomes

  1. Prognostic role of the blood and semen samples

    Metabolomics and microbiome signature fertile and infertile men predicting possible finding of spermatozoa

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2016 (actual). Primary completion is estimated for May 2026, 119 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2023
First posted
Dec 26, 2023
StartActual
Jun 1, 2016
Primary completionEst.
May 31, 2026
CompletionEst.
May 31, 2026
Last update
Dec 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06181851
Lead sponsor
IRCCS San Raffaele
Responsible party
Andrea Salonia (Professor, IRCCS San Raffaele) — Principal investigator
First posted
Dec 26, 2023
Start date
Jun 1, 2016
Primary completion
May 31, 2026 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Dec 26, 2023

Study contacts

Andrea Salonia, MD
Contact
salonia.andrea@hsr.it
02 2643 5661
Alessia d'Arma, MSc
Contact
darma.alessia@hsr.it
02 2643 5506

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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