Male InfertilityDHANCT02889341
Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
A study testing DHA in people with Male Infertility, run by Vida Recoletas Sevilla.
Trial summary
Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- DHA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2013to Mar 2017
- 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 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 1 year of infertility
- > 10 mill/ml of sperms
- Motility < 60% progressive
- Morphology < 2% (WHO 2010)
Who cannot join
- No meeting the inclusion criteria.
About this study
Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.
Read the detailed description
Prospective, randomized, double blind, placebo-controlled intervention study within individuals. Assisted reproduction unit and academic research laboratory. One hundred an eighty human semen samples from 60 infertile patients of IVI Sevilla clinic were finally included. Assessment of oxidative stress, apoptosis, lipid peroxidation, mitochondrial membrane potential, DNA fragmentation and standard sperm parameters before and after supplementation with different DHA doses (0.5, 1 and 2 g) or placebo for 1 and 3 months.
- Conditions
- Male Infertility
- Being tested
- DHA, Placebo
- Keywords
- Docosahexanoic Acid,, DNA fragmentation, male fertility, Sperm parameters improvements
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHADietary supplement
Also called Docosahexaenoic acid
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| 500 mg DHA/day | Active comparator | 500 mg DHA/day Receives: Dietary Supplement: DHA |
| 1g DHA/day | Active comparator | 1g DHA/day Receives: Dietary Supplement: DHA |
| 2g DHA/day | Active comparator | 2g DHA/day Receives: Dietary Supplement: DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm cell concentration
Measured in millions of sperm cells per ml of semen sample
Measured: Three months
Sperm cell motility
Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).
Measured: Three months
Sperm cell morphology
Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.
Measured: Three
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start22 Oct 2013
- Primary completion26 May 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889341
- Sponsor's protocol ID
- 1303-SEV-00-CG
- Acronym
- DHA
- Status last verified
- Dec 2016
- First submitted
- 4 Aug 2016
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
- ClinicalTrials.gov ID
- NCT02889341
- Acronym / sponsor ID
- DHA / 1303-SEV-00-CG
- Conditions
- Male Infertility
- Keywords
- Docosahexanoic Acid,, DNA fragmentation, male fertility, Sperm parameters improvements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Study start
- 22 Oct 2013 (actual)
- Primary completion
- 26 May 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 Sep 2016 (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.
Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.
Detailed description
Prospective, randomized, double blind, placebo-controlled intervention study within individuals. Assisted reproduction unit and academic research laboratory. One hundred an eighty human semen samples from 60 infertile patients of IVI Sevilla clinic were finally included. Assessment of oxidative stress, apoptosis, lipid peroxidation, mitochondrial membrane potential, DNA fragmentation and standard sperm parameters before and after supplementation with different DHA doses (0.5, 1 and 2 g) or placebo for 1 and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| 500 mg DHA/day | Active comparator | Dietary Supplement: DHA500 mg DHA/day |
| 1g DHA/day | Active comparator | Dietary Supplement: DHA1g DHA/day |
| 2g DHA/day | Active comparator | Dietary Supplement: DHA2g DHA/day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1 year of infertility
- > 10 mill/ml of sperms
- Motility < 60% progressive
- Morphology < 2% (WHO 2010)
Key exclusion criteria (1 listed)
- No meeting the inclusion criteria.
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 |
|---|---|---|
| DHAAlso: Docosahexaenoic acid | Dietary supplement | 1g DHA/day, 2g DHA/day, 500 mg DHA/day |
| Placebo | Other | Placebo |
Primary outcome
Sperm cell concentration
Time frame: Three months
Measured in millions of sperm cells per ml of semen sample
Sperm cell motility
Time frame: Three months
Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).
Sperm cell morphology
Time frame: Three
Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.
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 2 Aug 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DHA in people with Male Infertility, run by Vida Recoletas Sevilla.
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 4 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 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 cell concentration (time frame: Three months). The study lists 3 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 2 Aug 2017.