Oxidative Stress and Lipidomics in Male Infertility
This trial is active, not recruiting.
|Sponsor||University of Roma La Sapienza|
|Collaborator||Civic Hospital, Italy|
|Start date||February 2012|
|End date||October 2013|
|Trial size||120 participants|
|Trial identifier||NCT02062229, IULIANO_Rago|
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.
|Observational model||case control|
Subjects not affected by any disease and with normal seminal fluid characteristics
Infertile subjects with oligospermia
Infertile subjects with varicocele
Infertile subjects with asthenospermia
Oxysterol profiling in seminal fluid
time frame: 1 day
Fatty acids lipidomics
time frame: 1 day
Male participants from 18 years up to 60 years old.
- clinically healthy subjects and clinical healthy subjects with infertility
- subjects with endocrine, cardiovascular, metabolic, inflammatory and neurologic diseases or cancer
- subjects taking medicines and/or supplements
|Official title||Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility|
|Principal investigator||Rocco Rago, M.D.|
|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.|
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