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Completed

NCT Number: NCT02032251

Reduction of Sperm DNA Fragmentation by Oral Ginger

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men with idiopathic infertility or unexplained

Exclusion criteria

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

Treatment and study plan

oral administration of ginger

Drug

Oral administration of ginger in patients with infertility.

Other names: Administration of herbal drug

Placebo

Drug

Primary outcomes

  1. sperm DNA fragmentation

    Time frame: 3 months

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 9, 2014
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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