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

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.

Study Overview

• Status: Unknown
• Conditions: Male Infertility With Severe Oligo-terato-asteno-spermia
• Intervention / Treatment: Dietary supplement: Pomegranate pills

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 Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Einat Shalom-Paz, MD; Phone Number: 972544899155; Email: einatshalompaz@gmail.com
• Study Contact Backup: Name: Ellenbogen Adrian, MD; Phone Number: 973506246722; Email: ellenbogen@hy.health.gov.il

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
    • Contact: Reuma Barkan; Phone Number: 97246304223; Email: reuma@hy.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pregnancy	24 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROS (reactive oxidative stress )and Interleukins level in semen fluid	The unit for measure the ROS are Micromolar epicatechin equivalent	12 weeks

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Einat Shalom-Paz, MD, Hillel Yaffe Medical center, IVF unit, Hadera, Israel

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: July 14, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Estimate): August 7, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress
• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: 0059-13HYMC