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Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility. (Pomegranate)

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ClinicalTrials.gov Identifier: NCT01918163
Recruitment Status : Unknown
Verified July 2013 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 7, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Male Infertility With Severe Oligo-terato-asteno-spermia Dietary Supplement: Pomegranate pills Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.
Study Start Date : September 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: No Pills
Patients in this group will not receive Pomegranate pills.
Active Comparator: Pomegranate pills
The reccruited patient will receive pomegranate pills every day for 12 weeks. The control group will not be exposed for the pills.
 Dietary Supplement: Pomegranate pills


Outcome Measures
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Primary Outcome Measures :
  1. pregnancy [ Time Frame: 24 month ]

Secondary Outcome Measures :
  1. ROS (reactive oxidative stress )and Interleukins level in semen fluid [ Time Frame: 12 weeks ]
    The unit for measure the ROS are Micromolar epicatechin equivalent


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918163


Contacts
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Contact: Einat Shalom-Paz, MD 972544899155 einatshalompaz@gmail.com
Contact: Ellenbogen Adrian, MD 973506246722 ellenbogen@hy.health.gov.il

Locations
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Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Contact: Reuma Barkan    97246304223    reuma@hy.health.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Einat Shalom-Paz, MD Hillel Yaffe Medical center, IVF unit, Hadera, Israel
More Information
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01918163    
Other Study ID Numbers: 0059-13HYMC
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: July 2013
Keywords provided by Hillel Yaffe Medical Center:
pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress
Additional relevant MeSH terms:
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Infertility
Infertility, Male