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

NCT ID: NCT01918163

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Male Infertility With Severe Oligo-terato-asteno-spermia

Keywords

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pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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No Pills

Patients in this group will not receive Pomegranate pills.

Group Type NO_INTERVENTION

No interventions assigned to this group

Pomegranate pills

The reccruited patient will receive pomegranate pills every day for 12 weeks. The control group will not be exposed for the pills.

Group Type ACTIVE_COMPARATOR

Pomegranate pills

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Pomegranate pills

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Einat Shalom-Paz, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical center, IVF unit, Hadera, Israel

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Einat Shalom-Paz, MD

Role: CONTACT

Phone: 972544899155

Email: [email protected]

Ellenbogen Adrian, MD

Role: CONTACT

Phone: 973506246722

Email: [email protected]

Facility Contacts

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Reuma Barkan

Role: primary

Other Identifiers

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0059-13HYMC

Identifier Type: -

Identifier Source: org_study_id