Try our beta test site

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, IVI VALENCIA
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dietary DHA Supplementation on Sperm Quality.

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

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

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

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

  • 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.

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

  • 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:
  • Sperm in ejaculate [ Time Frame: 5 weeks ]
    Million of spermatozoa in eyaculate.

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

  • Sperm viability [ Time Frame: 5 weeks ]
    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

Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, IVI VALENCIA
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

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

ClinicalTrials.gov processed this record on February 23, 2017