Viewing Study NCT02032251


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Study NCT ID: NCT02032251
Status: COMPLETED
Last Update Posted: 2014-01-09
First Post: 2014-01-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Reduction of Sperm DNA Fragmentation by Oral Ginger
Sponsor: Royan Institute
Organization:

Study Overview

Official Title: Reduction of Sperm DNA Fragmentation by Oral Ginger (Zingiberofficinale) Extract Treatment
Status: COMPLETED
Status Verified Date: 2009-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: