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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01918163
First received: July 14, 2013
Last updated: August 6, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Male Infertility With Severe Oligo-terato-asteno-spermia
Dietary Supplement: Pomegranate pills
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • pregnancy [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ROS (reactive oxidative stress )and Interleukins level in semen fluid [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The unit for measure the ROS are Micromolar epicatechin equivalent


Estimated Enrollment: 55
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918163

Contacts
Contact: Einat Shalom-Paz, MD 972544899155 einatshalompaz@gmail.com
Contact: Ellenbogen Adrian, MD 973506246722 ellenbogen@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Reuma Barkan    97246304223    reuma@hy.health.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Einat Shalom-Paz, MD Hillel Yaffe Medical center, IVF unit, Hadera, Israel
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01918163     History of Changes
Other Study ID Numbers: 0059-13HYMC
Study First Received: July 14, 2013
Last Updated: August 6, 2013
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Hillel Yaffe Medical Center:
pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Female
Genital Diseases, Male
Contraceptives, Oral
Contraceptive Agents
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014