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Oxidative Stress and Lipidomics in Male Infertility

NCT ID: NCT02062229

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Male Infertility

Keywords

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oxidative stress oxysterols fatty acids seminal fluid

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Halthy controls

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

No interventions assigned to this group

Oligospermia

Infertile subjects with oligospermia

No interventions assigned to this group

Varicocele

Infertile subjects with varicocele

No interventions assigned to this group

Asthenospermia

Infertile subjects with asthenospermia

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Civic Hospital, Italy

OTHER

Sponsor Role collaborator

University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Luigi Iuliano

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rocco Rago, M.D.

Role: PRINCIPAL_INVESTIGATOR

Civic Hospital

Luigi Iuliano, M.D.

Role: STUDY_DIRECTOR

University of Roma La Sapienza

Locations

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Civic Hospital, Fertility Unit

Latina, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 27673576 (View on PubMed)

Other Identifiers

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IULIANO_Rago

Identifier Type: -

Identifier Source: org_study_id