Reduction of Sperm DNA Fragmentation by Oral Ginger

NCT ID: NCT02032251

Last Updated: 2014-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-11-30

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ginger

The patients with infertility that underwent oral administration of ginger.

Group Type EXPERIMENTAL

oral administration of ginger

Intervention Type DRUG

Oral administration of ginger in patients with infertility.

Placebo

The patients with infertility that receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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oral administration of ginger

Oral administration of ginger in patients with infertility.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Administration of herbal drug

Eligibility Criteria

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Inclusion Criteria

* men with idiopathic infertility or unexplained

Exclusion Criteria

* history of varicocele, genitourinary inflammation or infection
* history of cigarette smoking.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Ali DaliriHampa, MD

Role: STUDY_DIRECTOR

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

Eyed Jalil Hosseini, MD

Role: STUDY_DIRECTOR

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

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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Royan Institute

Tehran, , Iran

Site Status

Countries

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Iran

Related Links

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Other Identifiers

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royan-Emb-017

Identifier Type: -

Identifier Source: org_study_id

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