NCT00406874

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

November 30, 2006

Last Update Submit

June 3, 2013

Conditions

Infertility

Keywords

infertilitysemen qualitysexual functionblood pressureomega 3 fatsfolic acid

Outcome Measures

Primary Outcomes (2)

  • Questionaires regarding sexual function

    every 30 days

  • Semen analysis

    every 30 days

Secondary Outcomes (2)

  • blood pressure

    every 30 days

  • serum nitrate levels

    every 30 days

Interventions

omega 3 fatsDRUG

1,000 mg daily

folic acidDRUG

800 micrograms daily

Eligibility Criteria

Age35 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Partners medical Group

Redondo Beach, California, 90277, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • David R Meldrum, M.D.

    Reproductive Partners Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)