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

Basic Information

• 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

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.

Conditions

Male Infertility With Severe Oligo-terato-asteno-spermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Pomegranate pills

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Einat Shalom-Paz, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical center, IVF unit, Hadera, Israel

Locations

Hillel Yaffe Medical Center

Hadera, , Israel

Countries

Israel

Central Contacts

Einat Shalom-Paz, MD

Role: CONTACT

einatshalompaz@gmail.com

972544899155

Ellenbogen Adrian, MD

Role: CONTACT

ellenbogen@hy.health.gov.il

973506246722

Facility Contacts

Reuma Barkan

Role: primary

reuma@hy.health.gov.il

97246304223

Other Identifiers

0059-13HYMC

Identifier Type: -

Identifier Source: org_study_id