Poor Semen QualityNCT01357044
Effects of Plant Extracts on Semen Quality
A study testing Extracts of Punica granatum and Alpinia galanga in people with Poor Semen Quality, run by Horsens Hospital at 1 site in Denmark.
Trial summary
this is a prospective randomized placebo-controlled double-blinded trial investigating the effect of plant extracts from Alpinia galanga and Punica granatum on human semen quality. The investigators hypothesize that these plant extracts will improve semen quality. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Semen Quality
- What is being tested?
- Extracts of Punica granatum and Alpinia galanga
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Jul 2013
- Phase
- Interventional
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reduced semen quality
Who cannot join
- Total count of motile sperm less than 1 million sperm/ejaculate or more than 200 million sperm/ejaculate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Extract of Pomegranate Fruit and Galangal Rhizome Increases the Numbers of Motile Sperm: A Prospective, Randomised, Controlled, Double-Blinded Trial
this is a prospective randomized placebo-controlled double-blinded trial investigating the effect of plant extracts from Alpinia galanga and Punica granatum on human semen quality. The investigators hypothesize that these plant extracts will improve semen quality.
- Conditions
- Poor Semen Quality
- Being tested
- Extracts of Punica granatum and Alpinia galanga, Placebo
- Keywords
- Semen quality, Plant extracts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracts of Punica granatum and Alpinia galangaDietary supplement
Tablets, two in the morning and two in the evening
PlaceboDietary supplement
Tablets, two in the morning and two in the evening
| Study group | Role | What they receive |
|---|---|---|
| Plant extracts | Active comparator | Not described Receives: Dietary Supplement: Extracts of Punica granatum and Alpinia galanga |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of motile sperm per ejaculate
Measured: Each participant is given plant extract for three months with flanking semen analyses.
Secondary outcomes (1)
Morphology: percentage of morphologically abnormal sperm in the ejaculate
If we find an increase in the primary outcome measure in data from participants receiving plant extracts and not in those receiving placebo tablets, we wish to further investigate whether sperm morphology also improves when consuming the plant extracts, e.g. whether the percentage of abnormal sperm in an ejaculate decreases in the group of participants receiving the active plant extracts
Measured: Each participant is given plant extract for three months with flanking semen analyses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Poor Semen QualityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horsens Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Videns- og Forskningscenter for Alternativ Behandling
- Responsible party
- Principal investigator, Jens Fedder, Horsens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357044
- Sponsor's protocol ID
- LRB-SU-010
- Status last verified
- Oct 2014
- First submitted
- 17 May 2011
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fedder MD, Jakobsen HB, Giversen I, Christensen LP, Parner ET, Fedder J. An extract of pomegranate fruit and galangal rhizome increases the numbers of motile sperm: a prospective, randomised, controlled, double-blinded trial. PLoS One. 2014 Oct 2;9(9):e108532. doi: 10.1371/journal.pone.0108532. eCollection 2014.
PubMed 25275520
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extract of Pomegranate Fruit and Galangal Rhizome Increases the Numbers of Motile Sperm: A Prospective, Randomised, Controlled, Double-Blinded Trial
- ClinicalTrials.gov ID
- NCT01357044
- Acronym / sponsor ID
- LRB-SU-010
- Conditions
- Poor Semen Quality
- Keywords
- Semen quality, Plant extracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Horsens HospitalUniversity, hospital or other
- Collaborators
- Videns- og Forskningscenter for Alternativ Behandling
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 May 2011 (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 is a prospective randomized placebo-controlled double-blinded trial investigating the effect of plant extracts from Alpinia galanga and Punica granatum on human semen quality. The investigators hypothesize that these plant extracts will improve semen quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant extracts | Active comparator | Dietary Supplement: Extracts of Punica granatum and Alpinia galanga |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Reduced semen quality
Key exclusion criteria (1 listed)
- Total count of motile sperm less than 1 million sperm/ejaculate or more than 200 million sperm/ejaculate
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 |
|---|---|---|
| Extracts of Punica granatum and Alpinia galangaTablets, two in the morning and two in the evening | Dietary supplement | Plant extracts |
| PlaceboTablets, two in the morning and two in the evening | Dietary supplement | Placebo |
Primary outcome
Count of motile sperm per ejaculate
Time frame: Each participant is given plant extract for three months with flanking semen analyses.
1 secondary outcome
Morphology: percentage of morphologically abnormal sperm in the ejaculate
Time frame: Each participant is given plant extract for three months with flanking semen analyses.
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 Oct 2014.
- Derived from this study: PubMed 25275520Fedder MD, Jakobsen HB, Giversen I, Christensen LP, Parner ET, Fedder J. An extract of pomegranate fruit and galangal rhizome increases the numbers of motile sperm: a prospective, randomised, controlled, double-blinded trial. PLoS One. 2014 Oct 2;9(9):e108532. doi: 10.1371/journal.pone.0108532. eCollection 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracts of Punica granatum and Alpinia galanga in people with Poor Semen Quality, run by Horsens Hospital at 1 site in Denmark.
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 1 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 Oct 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 Denmark. 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.
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?
Count of motile sperm per ejaculate (time frame: Each participant is given plant extract for three months with flanking semen analyses.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357044, which also lists 1 linked publication.
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 Oct 2014; AzTrials last refreshed its copy on 6 Nov 2026.