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Reduction of Sperm DNA Fragmentation by Oral Ginger

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ClinicalTrials.gov Identifier: NCT02032251
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infertility Drug: oral administration of ginger Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Reduction of Sperm DNA Fragmentation by Oral Ginger (Zingiberofficinale) Extract Treatment
Study Start Date : December 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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 Name: Administration of herbal drug

Placebo Comparator: Placebo
The patients with infertility that receive placebo.
Drug: Placebo



Primary Outcome Measures :
  1. sperm DNA fragmentation [ Time Frame: 3 months ]
    Evaluation the percent of the reduction of sperm DNA fragmentation 3 months after ginger administration.


Secondary Outcome Measures :
  1. male hormones [ Time Frame: 3months ]
    Evaluation the effect of ginger on male hormones 3 months after oral administration.

  2. sperm count [ Time Frame: 3 months ]
    Evaluation the ginger on sperm count 3 months after oral administration.

  3. sperm motility [ Time Frame: 3 months ]
    Evaluation the effect of ginger on sperm motility 3 months after oral administration.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • men with idiopathic infertility or unexplained

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032251


Locations
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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Study Chair: Hamid Gourabi, PhD Head of Royan Institute
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

Additional Information:
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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02032251     History of Changes
Other Study ID Numbers: royan-Emb-017
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: October 2009
Keywords provided by Royan Institute:
Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female