Oxidative Stress and Lipidomics in Male Infertility

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02062229

Enrollment

120

Registered

2014-02-13

Start date

2012-02-29

Completion date

2016-06-30

Last updated

2015-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Keywords

oxidative stress, oxysterols, fatty acids, seminal fluid

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Vitamin E concentration in seminal fluid	1 day	the two main vitamin isoforms, alpha- and gamma-tocopherol, will be measured by GC/MS

Countries

Italy

Outcome results