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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Shaare Zedek Medical Center
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00479960
First received: May 28, 2007
Last updated: May 29, 2007
Last verified: November 2006
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Genders 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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00479960     History of Changes
Other Study ID Numbers: 022006
Study First Received: May 28, 2007
Last Updated: May 29, 2007
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on October 23, 2014