Clinical Trials Directory

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UnknownNCT02062229

Oxidative Stress and Lipidomics in Male Infertility

Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility

Status
Unknown
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
University of Roma La Sapienza · Academic / Other
Sex
Male
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2012-02-01
Primary completion
2013-10-01
Completion
2016-06-01
First posted
2014-02-13
Last updated
2015-12-11

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT02062229. Inclusion in this directory is not an endorsement.