A Preliminary Study on Effect of Omega-3 on Human Sperm
Effect of Dietary Supplementation With Omega-3 Fatty Acids on Human Sperm Characteristics, a Preliminary Study
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2007
CompletedFirst Posted
Study publicly available on registry
May 30, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMay 30, 2007
November 1, 2006
May 28, 2007
May 29, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sperm count
10 weeks
Secondary Outcomes (1)
sperm Lipid phase transition determination
10 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients with asthenozoospermia (low progressive motility), teratozoopermia (abnormal morphology) and/or oligozoospermia (low sperm count)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hadassah Medical Organizationlead
- Shaare Zedek Medical Centercollaborator
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ariel Revel, MD
Hadassah university hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 28, 2007
First Posted
May 30, 2007
Study Start
June 1, 2007
Study Completion
June 1, 2007
Last Updated
May 30, 2007
Record last verified: 2006-11