The Effects of Administration of Combined Docosahexaenoic Acid and Vitamin E Supplements on Spermatogram and Seminal Plasma Oxidative Stress in Infertile Men With Asthenozoospermia
1 other identifier
interventional
180
0 countries
N/A
Brief 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. Furthermore, the investigators added vitamin E to it to protect its unsaturated bonds which are susceptible to oxidation and production of free oxygen radicals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2013
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 16, 2015
June 1, 2015
1.2 years
May 1, 2013
June 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
sperm motility
spermatogram
12 weeks
Secondary Outcomes (2)
sperm count
12 weeks
seminal oxidative stress
12 weeks
Study Arms (4)
DHA plus vitamin E
EXPERIMENTALCap DHA 460mg plus vitamin E 600mg per day
VitaminE plus placebo
ACTIVE COMPARATORvitamin E 600 mg plus placebo
placebo plus placebo
PLACEBO COMPARATORDHA shaped placebo plus vitamin E shaped placebo
DHA plus placebo
ACTIVE COMPARATOR460 mg DHA plus placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32453396DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 3, 2013
Study Start
December 1, 2013
Primary Completion
February 1, 2015
Study Completion
May 1, 2015
Last Updated
June 16, 2015
Record last verified: 2015-06