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Effect of Omega 3 Fats on Sperm Quality and Sexual Function

This study has been terminated.
(reports indicating that increased folic acid intake may increase colin cancer)
Sponsor:
Information provided by (Responsible Party):
David R. Meldrum, M.D., Reproductive Partners Medical Group
ClinicalTrials.gov Identifier:
NCT00406874
First received: November 30, 2006
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose
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 Intervention Phase
Infertility
 Drug: omega 3 fats
Drug: folic acid
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Reproductive Partners Medical Group:

Primary Outcome Measures:
  • Questionaires regarding sexual function [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
  • Semen analysis [ Time Frame: every 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
  • serum nitrate levels [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
Enrollment: 6
Study Start Date: January 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: omega 3 fats
    1,000 mg daily
    Drug: folic acid
    800 micrograms daily
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.

  Eligibility
Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Genders 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
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: NCT00406874

Locations
United States, California
Reproductive Partners medical Group
Redondo beach, California, United States, 90277
Sponsors and Collaborators
Reproductive Partners Medical Group
Investigators
Principal Investigator: David R Meldrum, M.D. Reproductive Partners Medical Group
  More Information

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 
Study First Received: November 30, 2006
Last Updated: June 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Partners Medical Group:
infertility
semen quality
sexual function
 blood pressure
omega 3 fats
folic acid

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

ClinicalTrials.gov processed this record on September 23, 2016