Reduction of Sperm DNA Fragmentation by Oral Ginger

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: oral administration of ginger; Drug: Placebo

• Registration Number: NCT02032251
• Lead Sponsor: Royan Institute

Brief Summary

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

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.

Study Timeline

• Status Verified: 2009-10
• Study Start: 2009-12
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Study First Posted: 2014-01-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

Inclusion Criteria

• men with idiopathic infertility or unexplained

Exclusion Criteria

• history of varicocele, genitourinary inflammation or infection
• history of cigarette smoking.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ginger	oral administration of ginger	The patients with infertility that underwent oral administration of ginger.
Placebo	Placebo	The patients with infertility that receive placebo.

Primary Outcome Measures

Name	Time	Method
sperm DNA fragmentation	3 months	Evaluation the percent of the reduction of sperm DNA fragmentation 3 months after ginger administration.

Secondary Outcome Measures

Name	Time	Method
male hormones	3months	Evaluation the effect of ginger on male hormones 3 months after oral administration.
sperm count	3 months	Evaluation the ginger on sperm count 3 months after oral administration.
sperm motility	3 months	Evaluation the effect of ginger on sperm motility 3 months after oral administration.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of