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

IVI Sevilla

Status: Completed

Conditions: Male Infertility

Treatments: Other: Placebo; Dietary Supplement: DHA

Study type: Interventional

Funder types: Other

Identifiers

NCT02889341

1303-SEV-00-CG

Details and patient eligibility

About

Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

500 mg DHA/day

Active Comparator group

Description:

500 mg DHA/day

Treatment:

Dietary Supplement: DHA

1g DHA/day

Active Comparator group

Description:

1g DHA/day

Treatment:

Dietary Supplement: DHA

2g DHA/day

Active Comparator group

Description:

2g DHA/day

Treatment:

Dietary Supplement: DHA