Reduction of Sperm DNA Fragmentation by Oral Ginger

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Placebo; Drug: oral administration of ginger

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• men with idiopathic infertility or unexplained

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ginger; The patients with infertility that underwent oral administration of ginger.	Drug: oral administration of ginger; Oral administration of ginger in patients with infertility.; Other Names: Administration of herbal drug
Placebo Comparator: Placebo; The patients with infertility that receive placebo.	Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Director: Ali DaliriHampa, MD, Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine; Study Director: Eyed Jalil Hosseini, MD, Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine; Principal Investigator: Hani Department of Andrology, Reproductive Biomedicine Center, Roya, MSc, Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: royan-Emb-017