Oxidative Stress and Lipidomics in Male Infertility

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Civic Hospital, Italy
Information provided by (Responsible Party):
Luigi Iuliano, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT02062229
First received: February 7, 2014
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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
Male Infertility

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: July 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Halthy controls
Subjects not affected by any disease and with normal seminal fluid characteristics
Oligospermia
Infertile subjects with oligospermia
Varicocele
Infertile subjects with varicocele
Asthenospermia
Infertile subjects with asthenospermia

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects referring to an infertility center

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062229

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

No publications provided

Responsible Party: Luigi Iuliano, M.D., University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02062229     History of Changes
Other Study ID Numbers: IULIANO_Rago
Study First Received: February 7, 2014
Last Updated: February 11, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Roma La Sapienza:
oxidative stress
oxysterols
fatty acids
seminal fluid

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

ClinicalTrials.gov processed this record on September 16, 2014