Effect of Dietary DHA Supplementation on Sperm Quality

Effect of Dietary DHA Supplementation on Sperm Quality.

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

Study Overview

• Status: Completed
• Conditions: SPERM
• Intervention / Treatment: Dietary supplement: Sunflower oil; Dietary supplement: Docosahexanoic acid

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30007
    • Instituto Valenciano de Infertilidad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Diagnosis of male factor.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sperm concentration	million of spermatozoa per milimitre	5 weeks
Sperm motility	Percentage of motile sperm.	5 weeks
Sperm morphology	Percentage of sperm with normal morphology	5 weeks
Total capacity antioxidant	Total antioxidant capacity (TAC)is a colorimetric assay that measure the combined antioxidant activities of all its non enzymatic constituents in seminal plasma.	5 weeks
Sperm DNA damage.	DNA fragmentation analysis was evaluated by TUNEL test and measured by flow cytometry	5 weeks
Fatty acids measure.	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.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm in ejaculate	Million of spermatozoa in eyaculate.	5 weeks
Volume of ejaculate.	Eyaculated milliliters.	5 weeks
Sperm viability	Porcentage of sperm whitout membrane damage	5 weeks

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: IVI MUR 005-2009