NCT01368484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

June 7, 2011

Last Update Submit

June 7, 2011

Conditions

SPERM

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • Sperm in ejaculate

    5 weeks

  • Volume of ejaculate.

    5 weeks

  • Sperm viability

    5 weeks

Study Arms (2)

Sunflower oil

PLACEBO COMPARATOR
Dietary Supplement: Sunflower oil

Docosahexanoic acid

EXPERIMENTAL
Dietary Supplement: Docosahexanoic acid

Interventions

Sunflower oilDIETARY_SUPPLEMENT

1500 mg sunflower/day for 10 weeks

Sunflower oil
Docosahexanoic acidDIETARY_SUPPLEMENT

1500mg/day for 10 weeks

Docosahexanoic acid

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of male factor.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Valenciano de infertilidad

Murcia, Murcia, 30007, Spain

Location

MeSH Terms

Interventions

Sunflower Oil

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Martinez Soto, Juan Carlos

    IVI Murcia

    PRINCIPAL INVESTIGATOR

  • Landeras Gutierrez, Jose

    IVI Murcia

    STUDY DIRECTOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 8, 2011

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

ES(1)