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Oxidative Stress and Lipidomics in Male Infertility

U

University of Roma La Sapienza

Status

Unknown

Conditions

Male Infertility

Study type

Observational

Funder types

Other

Identifiers

NCT02062229
IULIANO_Rago

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

120 participants in 4 patient groups

Halthy controls
Description:
Subjects not affected by any disease and with normal seminal fluid characteristics
Oligospermia
Description:
Infertile subjects with oligospermia
Varicocele
Description:
Infertile subjects with varicocele
Asthenospermia
Description:
Infertile subjects with asthenospermia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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