Oxidative Stress and Lipidomics in Male Infertility

• Conditions: Male Infertility

• Registration Number: NCT02062229
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Infertility is a common problem, affecting perhaps one couple in six, the majority of whom now seek medical care. It is becoming a social challenge because it is responsible for personal and interpersonal discomfort and anxiety. A major obstacle to meaningful study of the epidemiology of male infertility is the difficulty in accurate diagnosis of the presence or absence of a problem. Traditionally, the diagnosis of male infertility is facilitated by the conventional assessment of the semen profile - constructed according to recognized guidelines (i.e. WHO) and including pH, cell count and motility - but no specific biomarkers are available.

We sought to determine the oxysterol and fatty acid lipidome with the ai of finding a lipid biomarker useful for the diagnosis of male infertility.

Detailed Description

Subjects referring to an outpatient infertility laboratory will be enrolled in the study. A complete clinical record is collected as well as a sperm and a fasting blood sample. Patients are stratified according to current guidelines focusing on sperm and anatomical characteristics. Sperm characteristics will be studied on fresh samples immediately after collection; blood samples will be centrifuged and plasma stored at -80°C until analysis that include routine glucose and lipid profile by commercial kits. Vitamin E (alpha- and gamma-tocopherol), oxysterols profiling, and fatty acids profiling is analyzed by state of the art gas chromatography-mass spectrometry (GC/MS) using isotope dilution methods.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-10
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• clinically healthy subjects and clinical healthy subjects with infertility

Exclusion Criteria

• subjects with endocrine, cardiovascular, metabolic, inflammatory and neurologic diseases or cancer
• subjects taking medicines and/or supplements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxysterol profiling in seminal fluid	1 day	Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS

Secondary Outcome Measures

Name	Time	Method
Fatty acids lipidomics	1 day	Profiling of fatty acids in seminal fluid will be assessed by GC/MS

Trial Locations

Locations (1)

Civic Hospital, Fertility Unit; 🇮🇹 Latina, Italy