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Effect of Dietary DHA Supplementation on Sperm Quality

This study has been completed.
Sponsor:
Collaborator:
University of Barcelona
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01368484
First received: June 7, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

The aim of this study is evaluated the effect of dietetic supplementation with DHA on human sperm quality, antioxidant capacity and sperm DNA damage.


Condition Intervention
SPERM
 Dietary Supplement: Sunflower oil
Dietary Supplement: Docosahexanoic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dietary DHA Supplementation on Sperm Quality.

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • sperm concentration [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    million of spermatozoa per milimitre

  • Sperm motility [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Percentage of motile sperm.

  • Sperm morphology [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Percentage of sperm with normal morphology

  • Total capacity antioxidant [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Total antioxidant capacity (TAC)is a colorimetric assay that measure the combined antioxidant activities of all its non enzymatic constituents in seminal plasma.

  • Sperm DNA damage. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    DNA fragmentation analysis was evaluated by TUNEL test and measured by flow cytometry

  • Fatty acids measure. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Fatty acid analysis in seminal plasma and spermatozoa were evaluated by gas chromatography.The percentage of each fatty acid class was expressed as percentage of total fatty acids.


Secondary Outcome Measures:
  • Sperm in ejaculate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Million of spermatozoa in eyaculate.

  • Volume of ejaculate. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Eyaculated milliliters.

  • Sperm viability [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Porcentage of sperm whitout membrane damage


Enrollment: 120
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sunflower oil Dietary Supplement: Sunflower oil
1500 mg sunflower/day for 10 weeks
Experimental: Docosahexanoic acid Dietary Supplement: Docosahexanoic acid
1500mg/day for 10 weeks

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of male factor.

Exclusion Criteria:

  • Metabolic and genetic diseases.
  • Oncological patients.
  • Patients with anticoagulants treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368484

Locations
Spain
Instituto Valenciano de infertilidad
Murcia, Spain, 30007
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
University of Barcelona
Investigators
Principal Investigator: Martinez Soto, Juan Carlos IVI-Murcia
Study Director: Landeras Gutierrez, Jose IVI-Murcia
Study Chair: Nicolas Arnau, Maria IVI-Murcia
Study Chair: Fernandez Olmedilla, Laura IVI-Murcia
Study Chair: Albero Pilar IVI-Murcia
Study Chair: Domingo JC University of Barcelona
  More Information

No publications provided

Responsible Party: Juan Carlos Martínez Soto., Instituto Valenciano de infertilidad, Murcia, Spain.
ClinicalTrials.gov Identifier: NCT01368484     History of Changes
Other Study ID Numbers: IVI MUR 005-2009
Study First Received: June 7, 2011
Last Updated: June 7, 2011
Health Authority: Spain: Ministry of Health

ClinicalTrials.gov processed this record on May 16, 2013