Clinical trial NCT02032251: Reduction of Sperm DNA Fragmentation by Oral Ginger
Official title: Reduction of Sperm DNA Fragmentation by Oral Ginger (Zingiberofficinale) Extract Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2014-01-09
Enrollment: 71
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* men with idiopathic infertility or unexplained

Exclusion Criteria:

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

Primary outcomes:
measure: sperm DNA fragmentation
timeFrame: 3 months
Secondary outcomes:
measure: male hormones
timeFrame: 3months
measure: sperm count
timeFrame: 3 months
measure: sperm motility
timeFrame: 3 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine
name: Ali DaliriHampa, MD
role: STUDY_DIRECTOR
affiliation: Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine
name: Eyed Jalil Hosseini, MD
role: STUDY_DIRECTOR
affiliation: Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine
name: Hani Department of Andrology, Reproductive Biomedicine Center, Roya, MSc
role: PRINCIPAL_INVESTIGATOR
References: