Oxidative Stress and Lipidomics in Male Infertility

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02062229
• Other study ID #: IULIANO_Rago
• Status: Active, not recruiting
• Phase: N/A
• First received: February 7, 2014
• Last updated: December 10, 2015
• Start date: February 2012
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Locations

Country	Name	City	State
Italy	Civic Hospital, Fertility Unit	Latina

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	Civic Hospital, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vitamin E concentration in seminal fluid	the two main vitamin isoforms, alpha- and gamma-tocopherol, will be measured by GC/MS	1 day	No
Primary	Oxysterol profiling in seminal fluid	Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS	1 day	No
Secondary	Fatty acids lipidomics	Profiling of fatty acids in seminal fluid will be assessed by GC/MS	1 day	No