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

Phase 3

• Conditions: Male Infertility With Severe Oligo-terato-asteno-spermia
• Interventions: Dietary Supplement: Pomegranate pills

• Registration Number: NCT01918163
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Study Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-14
• Study First Submitted QC: 2013-08-06
• Last Update Submitted: 2013-08-06
• Study First Posted: 2013-08-07
• Last Update Posted: 2013-08-07
• Study Start: 2013-09
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
pregnancy	24 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel