Oxidative Stress and Lipidomics in Male Infertility
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility|
- Oxysterol profiling in seminal fluid [ Time Frame: 1 day ] [ Designated as safety issue: No ]Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS
- Fatty acids lipidomics [ Time Frame: 1 day ] [ Designated as safety issue: No ]Profiling of fatty acids in seminal fluid will be assessed by GC/MS
- Vitamin E concentration in seminal fluid [ Time Frame: 1 day ] [ Designated as safety issue: No ]the two main vitamin isoforms, alpha- and gamma-tocopherol, will be measured by GC/MS
Biospecimen Retention: Samples Without DNA
Collection of male seminal fluid
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2015|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Subjects not affected by any disease and with normal seminal fluid characteristics
Infertile subjects with oligospermia
Infertile subjects with varicocele
Infertile subjects with asthenospermia
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02062229
|Civic Hospital, Fertility Unit|
|Latina, Italy, 04100|
|Principal Investigator:||Rocco Rago, M.D.||Civic Hospital|
|Study Director:||Luigi Iuliano, M.D.||Sapienza University of Rome|