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Reduction of Sperm DNA Fragmentation by Oral Ginger

Primary Purpose

Infertility

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

oral administration of ginger

Placebo

About this trial

This is an interventional treatment trial for Infertility focused on measuring Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

men with idiopathic infertility or unexplained

Exclusion Criteria:

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

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ginger

Placebo

Arm Description

The patients with infertility that underwent oral administration of ginger.

The patients with infertility that receive placebo.

Outcomes

Primary Outcome Measures

sperm DNA fragmentation

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

Secondary Outcome Measures

male hormones

Evaluation the effect of ginger on male hormones 3 months after oral administration.

sperm count

Evaluation the ginger on sperm count 3 months after oral administration.

sperm motility

Evaluation the effect of ginger on sperm motility 3 months after oral administration.

Full Information

NCT ID

NCT02032251

First Posted

January 8, 2014

Last Updated

January 8, 2014

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT02032251

Brief Title

Reduction of Sperm DNA Fragmentation by Oral Ginger

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ginger

Arm Type

Experimental

Arm Description

The patients with infertility that underwent oral administration of ginger.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The patients with infertility that receive placebo.

Intervention Type

Drug

Intervention Name(s)

oral administration of ginger

Other Intervention Name(s)

Administration of herbal drug

Intervention Description

Oral administration of ginger in patients with infertility.

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

sperm DNA fragmentation

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

male hormones

Description

Evaluation the effect of ginger on male hormones 3 months after oral administration.

Time Frame

3months

Title

sperm count

Description

Evaluation the ginger on sperm count 3 months after oral administration.

Time Frame

3 months

Title

sperm motility

Description

Evaluation the effect of ginger on sperm motility 3 months after oral administration.

Time Frame

3 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid Gourabi, PhD

Organizational Affiliation

Head of Royan Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ali DaliriHampa, MD

Organizational Affiliation

Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Eyed Jalil Hosseini, MD

Organizational Affiliation

Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hani Department of Andrology, Reproductive Biomedicine Center, Roya, MSc

Organizational Affiliation

Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royan Institute

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Links:

URL

http://Royaninstitute.org

Description

Related Info

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Reduction of Sperm DNA Fragmentation by Oral Ginger

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