NCT02889341

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 2, 2017

Status Verified

December 1, 2016

Enrollment Period

1.6 years

First QC Date

August 4, 2016

Last Update Submit

August 1, 2017

Conditions

Male Infertility

Keywords

Docosahexanoic Acid,DNA fragmentationmale fertilitySperm parameters improvements

Outcome Measures

Primary Outcomes (3)

  • Sperm cell concentration

    Measured in millions of sperm cells per ml of semen sample

    Three months

  • Sperm cell motility

    Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).

    Three months

  • Sperm cell morphology

    Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.

    Three

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

500 mg DHA/day

ACTIVE COMPARATOR

500 mg DHA/day

Dietary Supplement: DHA

1g DHA/day

ACTIVE COMPARATOR

1g DHA/day

Dietary Supplement: DHA

2g DHA/day

ACTIVE COMPARATOR

2g DHA/day

Dietary Supplement: DHA

Interventions

DHADIETARY_SUPPLEMENT
Also known as: Docosahexaenoic acid
1g DHA/day2g DHA/day500 mg DHA/day
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • year of infertility
  • \> 10 mill/ml of sperms
  • Motility \< 60% progressive
  • Morphology \< 2% (WHO 2010)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Male

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

September 5, 2016

Study Start

October 22, 2013

Primary Completion

May 26, 2015

Study Completion

March 1, 2017

Last Updated

August 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share