Oxidative Stress and Lipidomics in Male Infertility

NCT02062229 | Unknown DMC

• 1 other identifier: IULIANO_Rago
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility

Keywords

oxidative stress; oxysterols; fatty acids; seminal fluid

Outcome Measures

Primary Outcomes (1)

• Oxysterol profiling in seminal fluid

  Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS

  1 day

Secondary Outcomes (1)

• Fatty acids lipidomics

  1 day

Other Outcomes (1)

• Vitamin E concentration in seminal fluid

  1 day

Study Arms (4)

Halthy controls

Subjects not affected by any disease and with normal seminal fluid characteristics

Oligospermia

Infertile subjects with oligospermia

Varicocele

Infertile subjects with varicocele

Asthenospermia

Infertile subjects with asthenospermia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects referring to an infertility center

You may qualify if:

• clinically healthy subjects and clinical healthy subjects with infertility

You may not qualify if:

• subjects with endocrine, cardiovascular, metabolic, inflammatory and neurologic diseases or cancer
• subjects taking medicines and/or supplements

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Civic Hospital, Italy: collaborator

Study Sites (1)

Civic Hospital, Fertility Unit

Latina, 04100, Italy

Location

Related Publications (1)

• 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.

  PMID: 27673576 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of male seminal fluid

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Rocco Rago, M.D.

  Civic Hospital

  PRINCIPAL INVESTIGATOR

• Luigi Iuliano, M.D.

  University of Roma La Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 13, 2014
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2016
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

IT (1)