InfertilityPhase 2NCT02032251
Reduction of Sperm DNA Fragmentation by Oral Ginger
A Phase 2 study testing oral administration of ginger in people with Infertility, run by Royan Institute at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- oral administration of ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteIran
- Study dates
- Dec 2009to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- men with idiopathic infertility or unexplained
Who cannot join
- history of varicocele, genitourinary inflammation or infection
- history of cigarette smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Sperm DNA Fragmentation by Oral Ginger (Zingiberofficinale) Extract Treatment
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- oral administration of ginger, Placebo
- Keywords
- Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral administration of gingerDrug
Also called Administration of herbal drug
Oral administration of ginger in patients with infertility.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ginger | Experimental | The patients with infertility that underwent oral administration of ginger. Receives: Drug: oral administration of ginger |
| Placebo | Placebo comparator | The patients with infertility that receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm DNA fragmentation
Evaluation the percent of the reduction of sperm DNA fragmentation 3 months after ginger administration.
Measured: 3 months
Secondary outcomes (3)
male hormones
Evaluation the effect of ginger on male hormones 3 months after oral administration.
Measured: 3months
sperm count
Evaluation the ginger on sperm count 3 months after oral administration.
Measured: 3 months
sperm motility
Evaluation the effect of ginger on sperm motility 3 months after oral administration.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteAli DaliriHampa, MD, Study director, Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive BiomedicineEyed Jalil Hosseini, MD, Study director, Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive BiomedicineHani Department of Andrology, Reproductive Biomedicine Center, Roya, MSc, Principal investigator, Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032251
- Sponsor's protocol ID
- royan-Emb-017
- Status last verified
- Oct 2009
- First submitted
- 8 Jan 2014
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Sperm DNA Fragmentation by Oral Ginger (Zingiberofficinale) Extract Treatment
- ClinicalTrials.gov ID
- NCT02032251
- Acronym / sponsor ID
- royan-Emb-017
- Conditions
- Infertility
- Keywords
- Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ginger | Experimental | Drug: oral administration of gingerThe patients with infertility that underwent oral administration of ginger. |
| Placebo | Placebo comparator | Drug: PlaceboThe patients with infertility that receive placebo. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- men with idiopathic infertility or unexplained
Key exclusion criteria (2 listed)
- history of varicocele, genitourinary inflammation or infection
- history of cigarette smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral administration of gingerAlso: Administration of herbal drugOral administration of ginger in patients with infertility. | Drug | ginger |
| Placebo | Drug | Placebo |
Primary outcome
sperm DNA fragmentation
Time frame: 3 months
Evaluation the percent of the reduction of sperm DNA fragmentation 3 months after ginger administration.
3 secondary outcomes
male hormones
Time frame: 3months
sperm count
Time frame: 3 months
sperm motility
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Ali DaliriHampa, MD study director
Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine
Eyed Jalil Hosseini, MD study director
Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral administration of ginger in people with Infertility, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sperm DNA fragmentation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.