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Effect of Omega 3 Fats on Sperm Quality and Sexual Function

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ClinicalTrials.gov Identifier: NCT00406874
Recruitment Status : Terminated (reports indicating that increased folic acid intake may increase colin cancer)
First Posted : December 4, 2006
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
David R. Meldrum, M.D., Reproductive Partners Medical Group

Study Description
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Brief Summary:
This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid on sperm quality and sexual function in infertile men. It will also evaluate the effects on sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects continuing on both omega 3 fats and folic acid.

Condition or disease Intervention/treatment Phase
Infertility Drug: omega 3 fats Drug: folic acid Phase 2

Detailed Description:

Infertile men commonly have difficulty timing sexual relations around the time of ovulation. There is a high incidence of abnormal sperm morphology in infertile men. Omega 3 fats are known to increase the production of nitric oxide, which is the mediator of the male response, and folic acid is an important cofactor in the production of nitric oxide. Omega 3 fats are also important in the structure and function of cell membranes. There is a high incidence of deficient intake of omega 3 fats and folic acid in the U.S. population. Both folic acid and omega 3 fats are available as nutritional supplements and the doses used in this study are doses commonly recommended as nutritional supplements.

Comparison: Omega 3 fats plus folic acid will be compared with placebo plus folic acid in men age 35 to 55 attempting pregnancy with normal or mildly impaired semen quality. They will fill out dietary questionaires, questionaires regarding sexual function, and will have measurements of serum nitrates, blood pressure, and semen quality before and during use of these nutritional supplements. In men continuing on both omega 3 fats and folic acid, we will compare the effects of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo on their sexual function.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Omega 3 Fats on Sperm Quality and Sexual Function in Infertile Men Age 35-55
Study Start Date : January 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Arms and Interventions
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Intervention Details:
  • Drug: omega 3 fats
    1,000 mg daily
  • Drug: folic acid
    800 micrograms daily

Outcome Measures
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Primary Outcome Measures :
  1. Questionaires regarding sexual function [ Time Frame: every 30 days ]
  2. Semen analysis [ Time Frame: every 30 days ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: every 30 days ]
  2. serum nitrate levels [ Time Frame: every 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infertile men
  • age 35 to 55
  • expressing difficulty timing relations to their partner's ovulation

Exclusion Criteria:

  • hypertension, heart disease or other systemic diseases
  • fatty fish intake more than twice per week
  • marked semen abnormalities (less than 10 million sperm per ml, less than 20 % A plus B motility, more than 1 million WBC per HPF)
  • use of anticoagulants
  • must be willing to not take PDE 5 inhibitors during the study
  • use of other supplements is prohibited during the study
Contacts and Locations
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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): NCT00406874


Locations
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United States, California
Reproductive Partners medical Group
Redondo beach, California, United States, 90277
Sponsors and Collaborators
Reproductive Partners Medical Group
Investigators
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Principal Investigator: David R Meldrum, M.D. Reproductive Partners Medical Group
More Information
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Responsible Party: David R. Meldrum, M.D., Scientific Director, Reproductive Partners Medical Group
ClinicalTrials.gov Identifier: NCT00406874     History of Changes
Other Study ID Numbers: RPMG-1
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Keywords provided by David R. Meldrum, M.D., Reproductive Partners Medical Group:
infertility
semen quality
sexual function
 blood pressure
omega 3 fats
folic acid

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Folic Acid
Vitamin B Complex
Hematinics
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs