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

NCT ID: NCT02889341

Last Updated: 2017-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-22

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Male Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

500 mg DHA/day

500 mg DHA/day

Group Type ACTIVE_COMPARATOR

DHA

Intervention Type DIETARY_SUPPLEMENT

1g DHA/day

1g DHA/day

Group Type ACTIVE_COMPARATOR

DHA

Intervention Type DIETARY_SUPPLEMENT

2g DHA/day

2g DHA/day

Group Type ACTIVE_COMPARATOR

DHA

Intervention Type DIETARY_SUPPLEMENT

Interventions

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DHA

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Other Intervention Names

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Docosahexaenoic acid

Eligibility Criteria

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Inclusion Criteria

* 1 year of infertility
* \> 10 mill/ml of sperms
* Motility \< 60% progressive
* Morphology \< 2% (WHO 2010)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Vida Recoletas Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1303-SEV-00-CG

Identifier Type: -

Identifier Source: org_study_id

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