Back to resultsValuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility (DHA)
Primary Purpose
Male Infertility
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DHA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility focused on measuring Docosahexanoic Acid,, DNA fragmentation, male fertility, Sperm parameters improvements
Eligibility Criteria
Inclusion criteria:
- 1 year of infertility
- > 10 mill/ml of sperms
- Motility < 60% progressive
- Morphology < 2% (WHO 2010)
Exclusion criteria:
No meeting the inclusion criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
500 mg DHA/day
1g DHA/day
2g DHA/day
Arm Description
Placebo
500 mg DHA/day
1g DHA/day
2g DHA/day
Outcomes
Primary Outcome Measures
Sperm cell concentration
Measured in millions of sperm cells per ml of semen sample
Sperm cell motility
Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).
Sperm cell morphology
Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02889341
Brief Title
Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
Acronym
DHA
Official Title
Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 22, 2013 (Actual)
Primary Completion Date
May 26, 2015 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVI Sevilla
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
Docosahexanoic Acid,, DNA fragmentation, male fertility, Sperm parameters improvements
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
500 mg DHA/day
Arm Type
Active Comparator
Arm Description
500 mg DHA/day
Arm Title
1g DHA/day
Arm Type
Active Comparator
Arm Description
1g DHA/day
Arm Title
2g DHA/day
Arm Type
Active Comparator
Arm Description
2g DHA/day
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA
Other Intervention Name(s)
Docosahexaenoic acid
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Sperm cell concentration
Description
Measured in millions of sperm cells per ml of semen sample
Time Frame
Three months
Title
Sperm cell motility
Description
Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).
Time Frame
Three months
Title
Sperm cell morphology
Description
Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.
Time Frame
Three
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
1 year of infertility
> 10 mill/ml of sperms
Motility < 60% progressive
Morphology < 2% (WHO 2010)
Exclusion criteria:
No meeting the inclusion criteria.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
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