Clinical trial NCT02062229: Oxidative Stress and Lipidomics in Male Infertility
Official title: Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Male Infertility
Keywords: oxidative stress
oxysterols
fatty acids
seminal fluid
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Civic Hospital, Italy
First posted: 2014-02-13
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referring to an infertility center

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxysterol profiling in seminal fluid
timeFrame: 1 day
Secondary outcomes:
measure: Fatty acids lipidomics
timeFrame: 1 day
Other outcomes:
measure: Vitamin E concentration in seminal fluid
timeFrame: 1 day
Locations:
city: Latina
country: Italy
facility: Civic Hospital, Fertility Unit
Study officials:
affiliation: Civic Hospital
name: Rocco Rago, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Roma La Sapienza
name: Luigi Iuliano, M.D.
role: STUDY_DIRECTOR
References:
citation: Zerbinati C, Caponecchia L, Rago R, Leoncini E, Bottaccioli AG, Ciacciarelli M, Pacelli A, Salacone P, Sebastianelli A, Pastore A, Palleschi G, Boccia S, Carbone A, Iuliano L. Fatty acids profiling reveals potential candidate markers of semen quality. Andrology. 2016 Nov;4(6):1094-1101. doi: 10.1111/andr.12236. Epub 2016 Sep 27.