Back to resultsA Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
Primary Purpose
Male Infertility
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pomegranate juice
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility focused on measuring Male infertility
Eligibility Criteria
Inclusion Criteria:
- 12 healthy men aged 18-40
- normal sperm counts
Exclusion Criteria:
- History of undescended testes or surgery to the scrotal contents,
- History of marijuana or alcohol abuse, hot tub usage at least 3 months prior to entry into the study
- No alpha adrenergic medications within two weeks of entry into the study,
- No anabolic steroid use,
- No anticholinergic or antimuscarinic drugs, use of colchicine, cimetidine, sulfasalazine, antipsychotics, antidepressants, immunosuppressive drugs prior use of any chemotherapeutic drugs, or UTI on screening visit.
Sites / Locations
- Clinical Trials Program at University of California
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pomegranate juice
Arm Description
Pomegranate juice
Outcomes
Primary Outcome Measures
change in sperm counts
The primary outcome will be change in sperm counts relative to baseline with and without POM.
Secondary Outcome Measures
Change in Sperm count
The secondary outcome will be change in sperm counts relative to baseline with and without POM.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01595308
Brief Title
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
Official Title
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
POM Wonderful LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.
Detailed Description
To determine, in this pilot study, whether daily consumption of pomegranate juice (POM) affects the concentration, morphology or motility of sperm in healthy men. The purpose of the present pilot study is to examine the hypothesis that POM may improve semen parameters in men.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
Male infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pomegranate juice
Arm Type
Experimental
Arm Description
Pomegranate juice
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate juice
Intervention Description
Pomegranate juice
Primary Outcome Measure Information:
Title
change in sperm counts
Description
The primary outcome will be change in sperm counts relative to baseline with and without POM.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in Sperm count
Description
The secondary outcome will be change in sperm counts relative to baseline with and without POM.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
12 healthy men aged 18-40
normal sperm counts
Exclusion Criteria:
History of undescended testes or surgery to the scrotal contents,
History of marijuana or alcohol abuse, hot tub usage at least 3 months prior to entry into the study
No alpha adrenergic medications within two weeks of entry into the study,
No anabolic steroid use,
No anticholinergic or antimuscarinic drugs, use of colchicine, cimetidine, sulfasalazine, antipsychotics, antidepressants, immunosuppressive drugs prior use of any chemotherapeutic drugs, or UTI on screening visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Rajfer, MD
Organizational Affiliation
Institute of Urologic Oncology at UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials Program at University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
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