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Oxidative Stress and Lipidomics in Male Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Civic Hospital, Italy
Information provided by (Responsible Party):
Luigi Iuliano, 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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Estimated Study Completion Date : June 2016

Halthy controls
Subjects not affected by any disease and with normal seminal fluid characteristics
Infertile subjects with oligospermia
Infertile subjects with varicocele
Infertile subjects with asthenospermia

Primary Outcome Measures :
  1. Oxysterol profiling in seminal fluid [ Time Frame: 1 day ]
    Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS

Secondary Outcome Measures :
  1. Fatty acids lipidomics [ Time Frame: 1 day ]
    Profiling of fatty acids in seminal fluid will be assessed by GC/MS

Other Outcome Measures:
  1. 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
Collection of male seminal fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects referring to an infertility center

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02062229

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Civic Hospital, Fertility Unit
Latina, Italy, 04100
Sponsors and Collaborators
University of Roma La Sapienza
Civic Hospital, Italy
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Principal Investigator: Rocco Rago, M.D. Civic Hospital
Study Director: Luigi Iuliano, M.D. Sapienza University of Rome

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Luigi Iuliano, M.D., University of Roma La Sapienza Identifier: NCT02062229     History of Changes
Other Study ID Numbers: IULIANO_Rago
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Keywords provided by Luigi Iuliano, University of Roma La Sapienza:
oxidative stress
fatty acids
seminal fluid

Additional relevant MeSH terms:
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Infertility, Male
Genital Diseases, Male
Genital Diseases, Female