2015-Metabolomics&Microbiome-infertility

San Donato Group (GSD)

Status: Enrolling

Conditions: Azoospermia, Nonobstructive

Treatments: Other: Analysis of microbiome and metabolomics

Study type: Observational

Funder types: Other

Identifiers

NCT06181851

Metabolomics&microbiome

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 3 patient groups

Infertile men

Description:

Patients diagnosed with idiopathic non-obstructive azoospermia

Treatment:

Other: Analysis of microbiome and metabolomics

Fertile men

Description:

fertile subjects (pregnancy within 12 months of the start of the research by the couple, according to WHO 2010 criteria)

Treatment:

Other: Analysis of microbiome and metabolomics

Old fertile men

Description:

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)

Treatment:

Other: Analysis of microbiome and metabolomics