AsthenozoospermiaPhase 2/3NCT01846325
The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia
A Phase 2/3 study testing vitamin E and DHA in people with Asthenozoospermia, run by National Nutrition and Food Technology Institute.
Trial summary
Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve it. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Asthenozoospermia
- What is being tested?
- vitamin E and DHA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to May 2015
- Phase
- Phase 2/3
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Willing to participate in the study and filling out the informed consent form
- should be infertile (no conception after 12 months intercourse without any contraception)
- age 20-45 y.o, idiopathic asthenospermia according to WHO criteria
- normal hormonal profile
Who cannot join
- any infection in genitourinary (GU) tract
- any anatomical abnormality in GU tract
- any chronic disease during last 3 months
- any surgery in GU tract
- consumption of omega-3 fatty acids and/or vitamin E supplements during last 3 months
About this study
Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds which are susceptible to oxidation and production of free oxygen radicals.
- Conditions
- Asthenozoospermia
- Being tested
- vitamin E, DHA, placebo
- Medical subject headings
- Asthenozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin EDietary supplement
DHADietary supplement
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| DHA plus vitamin E | Experimental | Cap DHA 460mg plus vitamin E 600mg per day Receives: Dietary Supplement: vitamin E; Dietary Supplement: DHA |
| VitaminE plus placebo | Active comparator | vitamin E 600 mg plus placebo Receives: Dietary Supplement: vitamin E; Other: placebo |
| placebo plus placebo | Placebo comparator | DHA shaped placebo plus vitamin E shaped placebo Receives: Other: placebo |
| DHA plus placebo | Active comparator | 460 mg DHA plus placebo Receives: Dietary Supplement: DHA; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm motility
spermatogram
Measured: 12 weeks
Secondary outcomes (2)
sperm count
spermatogram
Measured: 12 weeks
seminal oxidative stress
ELISA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionMay 2015
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 AsthenozoospermiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846325
- Sponsor's protocol ID
- 046401
- Status last verified
- Jun 2015
- First submitted
- 1 May 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
Publications
Eslamian G, Amirjannati N, Noori N, Sadeghi MR, Hekmatdoost A. Effects of coadministration of DHA and vitamin E on spermatogram, seminal oxidative stress, and sperm phospholipids in asthenozoospermic men: a randomized controlled trial. Am J Clin Nutr. 2020 Sep 1;112(3):707-719. doi: 10.1093/ajcn/nqaa124.
PubMed 32453396
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia
- ClinicalTrials.gov ID
- NCT01846325
- Acronym / sponsor ID
- 046401
- Conditions
- Asthenozoospermia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 May 2013 (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.
Since docosahexaenoic acid (DHA) level in sperm membrane has been shown to be decreased in asthenozoospermic men, the investigators hypothesized that DHA supplementation may improve it. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds which are susceptible to oxidation and production of free oxygen radicals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DHA plus vitamin E | Experimental | Dietary Supplement: vitamin E, Dietary Supplement: DHACap DHA 460mg plus vitamin E 600mg per day |
| VitaminE plus placebo | Active comparator | Dietary Supplement: vitamin E, Other: placebovitamin E 600 mg plus placebo |
| placebo plus placebo | Placebo comparator | Other: placeboDHA shaped placebo plus vitamin E shaped placebo |
| DHA plus placebo | Active comparator | Dietary Supplement: DHA, Other: placebo460 mg DHA plus placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willing to participate in the study and filling out the informed consent form
- should be infertile (no conception after 12 months intercourse without any contraception)
- age 20-45 y.o, idiopathic asthenospermia according to WHO criteria
- normal hormonal profile
Key exclusion criteria (5 listed)
- any infection in genitourinary (GU) tract
- any anatomical abnormality in GU tract
- any chronic disease during last 3 months
- any surgery in GU tract
- consumption of omega-3 fatty acids and/or vitamin E supplements during last 3 months
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 |
|---|---|---|
| vitamin E | Dietary supplement | DHA plus vitamin E, VitaminE plus placebo |
| DHA | Dietary supplement | DHA plus placebo, DHA plus vitamin E |
| placebo | Other | DHA plus placebo, VitaminE plus placebo, placebo plus placebo |
Primary outcome
sperm motility
Time frame: 12 weeks
spermatogram
2 secondary outcomes
sperm count
Time frame: 12 weeks
seminal oxidative stress
Time frame: 12 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 16 Jun 2015.
- Derived from this study: PubMed 32453396Eslamian G, Amirjannati N, Noori N, Sadeghi MR, Hekmatdoost A. Effects of coadministration of DHA and vitamin E on spermatogram, seminal oxidative stress, and sperm phospholipids in asthenozoospermic men: a randomized controlled trial. Am J Clin Nutr. 2020 Sep 1;112(3):707-719. doi: 10.1093/ajcn/nqaa124.
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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 Phase 2/3 study testing vitamin E and DHA in people with Asthenozoospermia, run by National Nutrition and Food Technology Institute.
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 5 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 16 Jun 2015. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 motility (time frame: 12 weeks). 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 NCT01846325, 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 16 Jun 2015.