Oxidative Stress and Lipidomics in Male Infertility

December 10, 2015 updated by: Luigi Iuliano, University of Roma La Sapienza

Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to 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 Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Latina, Italy, 04100
        • Civic Hospital, Fertility Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Subjects referring to an infertility center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxysterol profiling in seminal fluid
Time Frame: 1 day
Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatty acids lipidomics
Time Frame: 1 day
Profiling of fatty acids in seminal fluid will be assessed by GC/MS
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this 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., University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IULIANO_Rago

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Male Infertility

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe