Effect of Dietary DHA Supplementation on Sperm Quality

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

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
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:

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


Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368484

Instituto Valenciano de infertilidad
Murcia, Spain, 30007
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
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
  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 April 17, 2014