Reduction of Sperm DNA Fragmentation by Oral Ginger

Study Overview
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Brief Summary
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This study is a randomized, double blind, controlled clinical trials assess the efficacy of the ginger oral treatment on sperm DNA fragmentation, sperm parameters and male hormones.

Detailed Description
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Sperm DNA fragmentation is known to affect male fertility. Previous findings have suggested the implication of oxidative stress in the etiology of this pathological condition. The present study was designed to find out DNA fragmentation in ejaculated spermatozoa can be reduced by oral treatment with Ginger extract. 71 men with unexplained or Idiopathic infertility were randomized between a Ginger treatment (500 milligram daily for 3months) group and a placebo group. Sperm DNA fragmentation was evaluated by Terminal deoxyribonucleotidyltransferase-mediated dUTP nick-end labeling assay (TUNEL) before and after treatment. No differences in basic sperm parameters were found between the Ginger treatment and the placebo group before or after treatment. However, the percentage of DNA-fragmented spermatozoa was markedly reduced (P< .005) in the Ginger treatment group after the treatment as compared with the pretreatment values). No difference in the pretreatment and post treatment incidence of sperm DNA fragmentation was observed in the placebo group. These data show that sperm DNA damage can be efficiently treated with oral Ginger extract administered during a relatively short time period.

Official Title
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Reduction of Sperm DNA Fragmentation by Oral Ginger (Zingiberofficinale) Extract Treatment

Conditions
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Infertility

Intervention / Treatment
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* Drug: oral administration of ginger
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men with idiopathic infertility or unexplained Exclusion Criteria: history of varicocele, genitourinary inflammation or infection history of cigarette smoking.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ginger<br>The patients with infertility that underwent oral administration of ginger. | Drug: oral administration of ginger<br>* Oral administration of ginger in patients with infertility.<br>* Other names: Administration of herbal drug;|
| Placebo Comparator: Placebo<br>The patients with infertility that receive placebo. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm DNA fragmentation | Evaluation the percent of the reduction of sperm DNA fragmentation 3 months after ginger administration. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| male hormones | Evaluation the effect of ginger on male hormones 3 months after oral administration. | 3months | 
| sperm count | Evaluation the ginger on sperm count 3 months after oral administration. | 3 months | 
| sperm motility | Evaluation the effect of ginger on sperm motility 3 months after oral administration. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine