This trial is active, not recruiting.

Condition male infertility
Sponsor University of Roma La Sapienza
Collaborator Civic Hospital, Italy
Start date February 2012
End date October 2013
Trial size 120 participants
Trial identifier NCT02062229, IULIANO_Rago


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Subjects not affected by any disease and with normal seminal fluid characteristics
Infertile subjects with oligospermia
Infertile subjects with varicocele
Infertile subjects with asthenospermia

Primary Outcomes

Oxysterol profiling in seminal fluid
time frame: 1 day

Secondary Outcomes

Fatty acids lipidomics
time frame: 1 day

Eligibility Criteria

Male participants from 18 years up to 60 years old.

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

Additional Information

Official title Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility
Principal investigator Rocco Rago, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Roma La Sapienza.