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

Study Overview
=================
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.

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

Conditions
-----------------
Male Infertility With Severe Oligo-terato-asteno-spermia

Intervention / Treatment
-----------------
* Dietary Supplement: Pomegranate pills


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Pills<br>Patients in this group will not receive Pomegranate pills. | |
| Active Comparator: Pomegranate pills<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress