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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02889341
First Posted: September 5, 2016
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IVI Sevilla
  Purpose
Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.

Condition Intervention
Male Infertility Dietary Supplement: DHA Other: Placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by IVI Sevilla:

Primary Outcome Measures:
  • 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.


Enrollment: 60
Actual Study Start Date: October 22, 2013
Study Completion Date: March 2017
Primary Completion Date: May 26, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: IVI Sevilla
ClinicalTrials.gov Identifier: NCT02889341     History of Changes
Other Study ID Numbers: 1303-SEV-00-CG
First Submitted: August 4, 2016
First Posted: September 5, 2016
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