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Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility (DHA)

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ClinicalTrials.gov Identifier: NCT02889341
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
IVI Sevilla

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.

Condition or disease Intervention/treatment Phase
Male Infertility Dietary Supplement: DHA Other: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
Actual Study Start Date : October 22, 2013
Actual Primary Completion Date : May 26, 2015
Actual Study Completion Date : March 2017


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Other: Placebo
Active Comparator: 500 mg DHA/day
500 mg DHA/day
Dietary Supplement: DHA
Other Name: Docosahexaenoic acid

Active Comparator: 1g DHA/day
1g DHA/day
Dietary Supplement: DHA
Other Name: Docosahexaenoic acid

Active Comparator: 2g DHA/day
2g DHA/day
Dietary Supplement: DHA
Other Name: Docosahexaenoic acid




Primary Outcome Measures :
  1. Sperm cell concentration [ Time Frame: Three months ]
    Measured in millions of sperm cells per ml of semen sample

  2. Sperm cell motility [ Time Frame: Three months ]
    Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).

  3. Sperm cell morphology [ Time Frame: Three ]
    Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Responsible Party: IVI Sevilla
ClinicalTrials.gov Identifier: NCT02889341     History of Changes
Other Study ID Numbers: 1303-SEV-00-CG
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by IVI Sevilla:
Docosahexanoic Acid,
DNA fragmentation
male fertility
Sperm parameters improvements

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female