Oxidative Stress and Lipidomics in Male Infertility
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|ClinicalTrials.gov Identifier: NCT02062229|
Recruitment Status : Unknown
Verified December 2015 by Luigi Iuliano, University of Roma La Sapienza.
Recruitment status was: Active, not recruiting
First Posted : February 13, 2014
Last Update Posted : December 11, 2015
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Observational Model:||Case Control|
|Official Title:||Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility|
|Study Start Date :||February 2012|
|Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||June 2016|
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 ]Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS
- Fatty acids lipidomics [ Time Frame: 1 day ]Profiling of fatty acids in seminal fluid will be assessed by GC/MS
- Vitamin E concentration in seminal fluid [ Time Frame: 1 day ]the two main vitamin isoforms, alpha- and gamma-tocopherol, will be measured by GC/MS
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|