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

Male Infertility With Severe Oligo-terato-asteno-spermia Clinical Trial

— Pomegranate  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01918163
• Other study ID #: 0059-13HYMC
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 14, 2013
• Last updated: August 6, 2013
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: July 2013
• Source: Hillel Yaffe Medical Center
• Contact: Einat Shalom-Paz, MD
• Phone: 972544899155
• Email: einatshalompaz[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility With Severe Oligo-terato-asteno-spermia

Intervention

Dietary Supplement:
• Pomegranate pills

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy		24 month	No
Secondary	ROS (reactive oxidative stress )and Interleukins level in semen fluid	The unit for measure the ROS are Micromolar epicatechin equivalent	12 weeks	No