Back to resultsAnti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility. (Pomegranate)
Primary Purpose
Male Infertility With Severe Oligo-terato-asteno-spermia
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Pomegranate pills
Sponsored by
About this trial
This is an interventional supportive care trial for Male Infertility With Severe Oligo-terato-asteno-spermia focused on measuring pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress
Eligibility Criteria
Inclusion Criteria:
- TMC of less than 5 million spermatogonia in native sperm and morphology less than 4% by Kruger criteria.
Exclusion Criteria:
- sensitivity to Pomegranate
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No Pills
Pomegranate pills
Arm Description
Patients in this group will not receive Pomegranate pills.
The reccruited patient will receive pomegranate pills every day for 12 weeks. The control group will not be exposed for the pills.
Outcomes
Primary Outcome Measures
pregnancy
Secondary Outcome Measures
ROS (reactive oxidative stress )and Interleukins level in semen fluid
The unit for measure the ROS are Micromolar epicatechin equivalent
Full Information
NCT ID
NCT01918163
First Posted
July 14, 2013
Last Updated
August 6, 2013
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01918163
Brief Title
Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.
Acronym
Pomegranate
Official Title
Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Some animal studies revealed that the pomegranate juice may improve sperm quality in terms of concentration, motility and morphology, as well as in fertilization rate.
Minor data is available regarding the influence on male sperm.
Detailed Description
Pomegranate contains a high concentration of vitamins ( C, B1, B2, B3, B5), potassium, Magnesium , Zinc and is a good source for polyphenols .Polyphenols molecules have been found to possess antioxidant properties and may effects the expression of different genes . Recent studies indicate that among foods that contain polyphenols, juice extracted from the pomegranate has the highest concentration of measurable polyphenols . Pomegranates have shown inhibitory effect on NF-κB and the MAP kinases JNK and ERK, which are critical steps in the cascade of events leading to inflammatory response. The NF- κB pathway is activated in response to bacterial infection and initiates the inflammatory cascade, which may explain the protective effect of Pomegranates on bacterial infections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility With Severe Oligo-terato-asteno-spermia
Keywords
pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No Pills
Arm Type
No Intervention
Arm Description
Patients in this group will not receive Pomegranate pills.
Arm Title
Pomegranate pills
Arm Type
Active Comparator
Arm Description
The reccruited patient will receive pomegranate pills every day for 12 weeks. The control group will not be exposed for the pills.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate pills
Primary Outcome Measure Information:
Title
pregnancy
Time Frame
24 month
Secondary Outcome Measure Information:
Title
ROS (reactive oxidative stress )and Interleukins level in semen fluid
Description
The unit for measure the ROS are Micromolar epicatechin equivalent
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
TMC of less than 5 million spermatogonia in native sperm and morphology less than 4% by Kruger criteria.
Exclusion Criteria:
sensitivity to Pomegranate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Einat Shalom-Paz, MD
Phone
972544899155
Email
einatshalompaz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ellenbogen Adrian, MD
Phone
973506246722
Email
ellenbogen@hy.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einat Shalom-Paz, MD
Organizational Affiliation
Hillel Yaffe Medical center, IVF unit, Hadera, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reuma Barkan
Phone
97246304223
Email
reuma@hy.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.
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