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A Preliminary Study on Effect of Omega-3 on Human Sperm

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00479960
First Posted: May 30, 2007
Last Update Posted: July 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Shaare Zedek Medical Center
Information provided by:
Hadassah Medical Organization
  Purpose

The phospholipids of mammalian spermatozoa possess a distinctive fatty acid composition with high proportion of long chain polyunsaturated fatty acids. The lipid composition is a major determinant of the membrane flexibility and sperm motility required for proper fertilization. It also influences the sperm plasma membrane's fluidity, chilling sensitivity and thermotropic lipid phase transition (LPT) and these parameters determine our ability to cryopreserve these cells. Our hypotheses is that by providing dietary supplementation of omega-3 polyunsaturated fatty acids an improvement of sperm parameters (number, motility, viability) can be achieved. We also expect alteration spermatozoal plasma membrane fatty acid composition, making it more chilling resistant.

Experimental methodology: 1) Characterize fatty acid composition of the spermatozoa of normal and abnormal spermatozoa by gas chromatography. 2) Characterize sperm plasma membrane LPT by FTIR spectrometer. 3) Run a randomized double-blind, placebo controlled, crossed-over dietary fatty acid supplementation pilot trial in human sub-fertile patients. Large scale trial will follow, if justified. In both trials sperm characterization of each participant will be conducted before, during and following the trial.

Subfertile males will benefit greatly if their sperm parameters can be improved and cryopreserved while ensuring enhanced post-thawing survival. We believe that changing the fatty acid composition of sperm plasma membrane by simple dietary means will open the way to improve the fertility of those that needs it the most.


Condition Intervention Phase
Oligospermia Behavioral: commercially available omega-3 fatty acids supplementation Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Dietary Supplementation With Omega-3 Fatty Acids on Human Sperm Characteristics, a Preliminary Study

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • sperm count [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • sperm Lipid phase transition determination [ Time Frame: 10 weeks ]

Estimated Enrollment: 20
Study Start Date: June 2007
Estimated Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with asthenozoospermia (low progressive motility), teratozoopermia (abnormal morphology) and/or oligozoospermia (low sperm count)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479960


Contacts
Contact: Abraham Benchetrit, MD 97250-8962566 benchet@012.net.il
Contact: Ariel Revel, MD 97226776424 arielrevel2@gmail.com

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Principal Investigator: Avraham Benchetrit, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Shaare Zedek Medical Center
Investigators
Principal Investigator: Ariel Revel, MD Hadassah university hospital
  More Information

ClinicalTrials.gov Identifier: NCT00479960     History of Changes
Other Study ID Numbers: 022006
First Submitted: May 28, 2007
First Posted: May 30, 2007
Last Update Posted: July 25, 2007
Last Verified: November 2006

Keywords provided by Hadassah Medical Organization:
Asthenozoospermia
Azoospermia
Oligospermia
Omega-3
Fatty Acids

Additional relevant MeSH terms:
Oligospermia
Infertility, Male
Infertility
Genital Diseases, Male