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
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: oral administration of ginger Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
- sperm DNA fragmentation [ Time Frame: 3 months ]Evaluation the percent of the reduction of sperm DNA fragmentation 3 months after ginger administration.
- male hormones [ Time Frame: 3months ]Evaluation the effect of ginger on male hormones 3 months after oral administration.
- sperm count [ Time Frame: 3 months ]Evaluation the ginger on sperm count 3 months after oral administration.
- sperm motility [ Time Frame: 3 months ]Evaluation the effect of ginger on sperm motility 3 months after oral administration.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032251
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|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|