SPERMNCT01368484
Effect of Dietary DHA Supplementation on Sperm Quality
A study testing Sunflower oil and Docosahexanoic acid in people with SPERM, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
The aim of this study is evaluated the effect of dietetic supplementation with DHA on human sperm quality, antioxidant capacity and sperm DNA damage. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- SPERM
- What is being tested?
- Sunflower oil and Docosahexanoic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2009to Mar 2011
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of male factor.
Who cannot join
- Metabolic and genetic diseases.
- Oncological patients.
- Patients with anticoagulants treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dietary DHA Supplementation on Sperm Quality.
The aim of this study is evaluated the effect of dietetic supplementation with DHA on human sperm quality, antioxidant capacity and sperm DNA damage.
- Conditions
- SPERM
- Being tested
- Sunflower oil, Docosahexanoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunflower oilDietary supplement
1500 mg sunflower/day for 10 weeks
Docosahexanoic acidDietary supplement
1500mg/day for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sunflower oil | Placebo comparator | Not described Receives: Dietary Supplement: Sunflower oil |
| Docosahexanoic acid | Experimental | Not described Receives: Dietary Supplement: Docosahexanoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm concentration
million of spermatozoa per milimitre
Measured: 5 weeks
Sperm motility
Percentage of motile sperm.
Measured: 5 weeks
Sperm morphology
Percentage of sperm with normal morphology
Measured: 5 weeks
Total capacity antioxidant
Total antioxidant capacity (TAC)is a colorimetric assay that measure the combined antioxidant activities of all its non enzymatic constituents in seminal plasma.
Measured: 5 weeks
Sperm DNA damage.
DNA fragmentation analysis was evaluated by TUNEL test and measured by flow cytometry
Measured: 5 weeks
Fatty acids measure.
Fatty acid analysis in seminal plasma and spermatozoa were evaluated by gas chromatography.The percentage of each fatty acid class was expressed as percentage of total fatty acids.
Measured: 5 weeks
Secondary outcomes (3)
Sperm in ejaculate
Million of spermatozoa in eyaculate.
Measured: 5 weeks
Volume of ejaculate.
Eyaculated milliliters.
Measured: 5 weeks
Sperm viability
Porcentage of sperm whitout membrane damage
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SPERMStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Investigators
- Martinez Soto, Juan Carlos, Principal investigator, IVI MurciaLanderas Gutierrez, Jose, Study director, IVI MurciaNicolas Arnau, Maria, Study chair, IVI MurciaFernandez Olmedilla, Laura, Study chair, IVI MurciaAlbero Pilar, Study chair, IVI MurciaDomingo JC, Study chair, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368484
- Sponsor's protocol ID
- IVI MUR 005-2009
- Status last verified
- Jun 2011
- First submitted
- 7 Jun 2011
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary DHA Supplementation on Sperm Quality.
- ClinicalTrials.gov ID
- NCT01368484
- Acronym / sponsor ID
- IVI MUR 005-2009
- Conditions
- SPERM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Jun 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.
The aim of this study is evaluated the effect of dietetic supplementation with DHA on human sperm quality, antioxidant capacity and sperm DNA damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunflower oil | Placebo comparator | Dietary Supplement: Sunflower oil |
| Docosahexanoic acid | Experimental | Dietary Supplement: Docosahexanoic acid |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of male factor.
Key exclusion criteria (3 listed)
- Metabolic and genetic diseases.
- Oncological patients.
- Patients with anticoagulants treatment.
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 |
|---|---|---|
| Sunflower oil1500 mg sunflower/day for 10 weeks | Dietary supplement | Sunflower oil |
| Docosahexanoic acid1500mg/day for 10 weeks | Dietary supplement | Docosahexanoic acid |
Primary outcome
sperm concentration
Time frame: 5 weeks
million of spermatozoa per milimitre
Sperm motility
Time frame: 5 weeks
Percentage of motile sperm.
Sperm morphology
Time frame: 5 weeks
Percentage of sperm with normal morphology
Total capacity antioxidant
Time frame: 5 weeks
Total antioxidant capacity (TAC)is a colorimetric assay that measure the combined antioxidant activities of all its non enzymatic constituents in seminal plasma.
Sperm DNA damage.
Time frame: 5 weeks
DNA fragmentation analysis was evaluated by TUNEL test and measured by flow cytometry
Fatty acids measure.
Time frame: 5 weeks
Fatty acid analysis in seminal plasma and spermatozoa were evaluated by gas chromatography.The percentage of each fatty acid class was expressed as percentage of total fatty acids.
3 secondary outcomes
Sperm in ejaculate
Time frame: 5 weeks
Volume of ejaculate.
Time frame: 5 weeks
Sperm viability
Time frame: 5 weeks
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 8 Jun 2011.
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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.
Martinez Soto, Juan Carlos principal investigator
IVI Murcia
Landeras Gutierrez, Jose study director
IVI Murcia
Nicolas Arnau, Maria study chair
IVI Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunflower oil and Docosahexanoic acid in people with SPERM, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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 3 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 8 Jun 2011. 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 Spain. 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?
sperm concentration (time frame: 5 weeks). The study lists 6 primary outcomes in all. 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 8 Jun 2011.