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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
Sponsor:
Collaborator:
Civic Hospital, Italy
Information provided by (Responsible Party):
Luigi Iuliano, University of Roma La Sapienza

Tracking Information
First Submitted Date February 7, 2014
First Posted Date February 13, 2014
Last Update Posted Date December 11, 2015
Study Start Date February 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2014)
Oxysterol profiling in seminal fluid [ Time Frame: 1 day ]
Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02062229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 11, 2014)
Fatty acids lipidomics [ Time Frame: 1 day ]
Profiling of fatty acids in seminal fluid will be assessed by GC/MS
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 11, 2014)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Oxidative Stress and Lipidomics in Male Infertility
Official Title Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility
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.

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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Collection of male seminal fluid
Sampling Method Non-Probability Sample
Study Population Subjects referring to an infertility center
Condition Male Infertility
Intervention Not Provided
Study 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
Publications * Zerbinati C, Caponecchia L, Rago R, Leoncini E, Bottaccioli AG, Ciacciarelli M, Pacelli A, Salacone P, Sebastianelli A, Pastore A, Palleschi G, Boccia S, Carbone A, Iuliano L. Fatty acids profiling reveals potential candidate markers of semen quality. Andrology. 2016 Nov;4(6):1094-1101. doi: 10.1111/andr.12236. Epub 2016 Sep 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 11, 2014)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2016
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02062229
Other Study ID Numbers IULIANO_Rago
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Luigi Iuliano, University of Roma La Sapienza
Study Sponsor University of Roma La Sapienza
Collaborators Civic Hospital, Italy
Investigators
Principal Investigator: Rocco Rago, M.D. Civic Hospital
Study Director: Luigi Iuliano, M.D. Sapienza University of Rome
PRS Account University of Roma La Sapienza
Verification Date December 2015