2015-Metabolomics&Microbiome-infertility

NCT ID: NCT06181851

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2026-05-31

Brief Summary

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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

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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

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Azoospermia, Nonobstructive

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Infertile men

Patients diagnosed with idiopathic non-obstructive azoospermia

Analysis of microbiome and metabolomics

Intervention Type OTHER

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)

Analysis of microbiome and metabolomics

Intervention Type OTHER

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)

Analysis of microbiome and metabolomics

Intervention Type OTHER

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

Interventions

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Analysis of microbiome and metabolomics

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Andrea Salonia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Salonia, MD

Role: CONTACT

Phone: 02 2643 5661

Email: [email protected]

Alessia d'Arma, MSc

Role: CONTACT

Phone: 02 2643 5506

Email: [email protected]

Facility Contacts

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Alessia d'Arma, PhD

Role: primary

Other Identifiers

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Metabolomics&microbiome

Identifier Type: -

Identifier Source: org_study_id