Effect of Dietary DHA Supplementation on Sperm Quality

SPERM Clinical Trial

Official title:

Effect of Dietary DHA Supplementation on Sperm Quality.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368484
• Other study ID #: IVI MUR 005-2009
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: June 7, 2011
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of male factor.

Exclusion Criteria:

• Metabolic and genetic diseases.

• Oncological patients.

• Patients with anticoagulants treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• SPERM

Intervention

Dietary Supplement:
• Sunflower oil
1500 mg sunflower/day for 10 weeks
• Docosahexanoic acid
1500mg/day for 10 weeks

Locations

Country	Name	City	State
Spain	Instituto Valenciano de infertilidad	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA	University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sperm concentration	million of spermatozoa per milimitre	5 weeks	No
Primary	Sperm motility	Percentage of motile sperm.	5 weeks	No
Primary	Sperm morphology	Percentage of sperm with normal morphology	5 weeks	No
Primary	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	No
Primary	Sperm DNA damage.	DNA fragmentation analysis was evaluated by TUNEL test and measured by flow cytometry	5 weeks	No
Primary	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	No
Secondary	Sperm in ejaculate	Million of spermatozoa in eyaculate.	5 weeks	No
Secondary	Volume of ejaculate.	Eyaculated milliliters.	5 weeks	No
Secondary	Sperm viability	Porcentage of sperm whitout membrane damage	5 weeks	No