NCT01595308

Brief Summary

How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

1.1 years

First QC Date

April 4, 2012

Last Update Submit

May 10, 2012

Conditions

Male Infertility

Keywords

Male infertility

Outcome Measures

Primary Outcomes (1)

  • change in sperm counts

    The primary outcome will be change in sperm counts relative to baseline with and without POM.

    Baseline and 6 months

Secondary Outcomes (1)

  • Change in Sperm count

    6 months

Study Arms (1)

Pomegranate juice

EXPERIMENTAL

Pomegranate juice

Dietary Supplement: Pomegranate juice

Interventions

Pomegranate juiceDIETARY_SUPPLEMENT

Pomegranate juice

Pomegranate juice

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men aged 18-40
  • normal sperm counts

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Program at University of California

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Jacob Rajfer, MD

    Institute of Urologic Oncology at UCLA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2012

First Posted

May 10, 2012

Study Start

April 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

US(1)