Reduction of Sperm DNA Fragmentation by Oral Ginger

Royan Institute

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: Placebo; Drug: oral administration of ginger

Study type: Interventional

Funder types: Other

Identifiers

NCT02032251

royan-Emb-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• men with idiopathic infertility or unexplained

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

71 participants in 2 patient groups, including a placebo group

ginger

Experimental group

Description:

The patients with infertility that underwent oral administration of ginger.

Treatment:

Drug: oral administration of ginger

Placebo

Placebo Comparator group

Description:

The patients with infertility that receive placebo.

Treatment:

Drug: Placebo