Effect of Dietary DHA Supplementation on Sperm Quality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01368484
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : June 8, 2011
University of Barcelona
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary:
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 or disease Intervention/treatment Phase
SPERM Dietary Supplement: Sunflower oil Dietary Supplement: Docosahexanoic acid Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dietary DHA Supplementation on Sperm Quality.
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. sperm concentration [ Time Frame: 5 weeks ]
    million of spermatozoa per milimitre

  2. Sperm motility [ Time Frame: 5 weeks ]
    Percentage of motile sperm.

  3. Sperm morphology [ Time Frame: 5 weeks ]
    Percentage of sperm with normal morphology

  4. Total capacity antioxidant [ Time Frame: 5 weeks ]
    Total antioxidant capacity (TAC)is a colorimetric assay that measure the combined antioxidant activities of all its non enzymatic constituents in seminal plasma.

  5. Sperm DNA damage. [ Time Frame: 5 weeks ]
    DNA fragmentation analysis was evaluated by TUNEL test and measured by flow cytometry

  6. Fatty acids measure. [ Time Frame: 5 weeks ]
    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 :
  1. Sperm in ejaculate [ Time Frame: 5 weeks ]
    Million of spermatozoa in eyaculate.

  2. Volume of ejaculate. [ Time Frame: 5 weeks ]
    Eyaculated milliliters.

  3. Sperm viability [ Time Frame: 5 weeks ]
    Porcentage of sperm whitout membrane damage

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of male factor.

Exclusion Criteria:

  • Metabolic and genetic diseases.
  • Oncological patients.
  • Patients with anticoagulants treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01368484

Instituto Valenciano de infertilidad
Murcia, Spain, 30007
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
University of Barcelona
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

Responsible Party: Juan Carlos Martínez Soto., Instituto Valenciano de infertilidad, Murcia, Spain. Identifier: NCT01368484     History of Changes
Other Study ID Numbers: IVI MUR 005-2009
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011