The Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality

NCT06950203 | Recruiting

• 1 other identifier: VLC 2024 01 Fertility
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study will enrol men that have a poor sperm quality. They will take either a placebo or fish oil capsule (2 per day) for 3 months. At the beginning and end of the study the participant will be asked for a sperm sample for measuring quality parameters.

Conditions

Infertility, Male

Keywords

VLCFA; VLC-PUFA; Very long chain polyunsaturated fatty acids; fertility; supplement

Outcome Measures

Primary Outcomes (1)

• Total Progressive Motile count will be measured pre- and post-intervention and compared to the comparator arm.

  The motile count will be performed by competent operators at each clinical site.

  From baseline to end of intervention at 3 months

Study Arms (2)

Placebo

ACTIVE COMPARATOR

DHA fish oil to match DHA content in active arm

Dietary Supplement: Comparator arm (DHA)

VLC-PUFA

EXPERIMENTAL

EPAX EVOLVE 05 containing Very Long Chain Polyunsaturated Fatty Acids

Dietary Supplement: Very Long Chain Polyunsaturated Fatty Acids

Interventions

Very Long Chain Polyunsaturated Fatty Acids DIETARY_SUPPLEMENT

Fish oil with DHA and VLCPUFA

VLC-PUFA

Comparator arm (DHA) DIETARY_SUPPLEMENT

Oil containing equal DHA content to active arm

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Males
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men aged 18-55
• Referred for or claiming a semen analysis.
• Willing to have at least 2 days abstinence of sexual activity prior to a sperm sample being taken.
• Reduced semen quality defined as:
• Progressive motility: \<30%
• Willing to refrain from omega-3/cod liver oil supplementation during the study. Use of other supplements is allowed.

You may not qualify if:

• Known allergy to fish products
• Historically, known, or suspected bacterial infection in reproductive organs
• Varicocele suspected from physical examination
• Azoospermia
• Diagnosis of diabetes (type 2)
• Diagnosis of Crohn´s Disease
• Inferior semen quality due to medical reasons, such as cryptorchidism (via questionnaire/medical records) -

Sponsors & Collaborators

• Epax Norway AS: lead

Study Sites (1)

Medicus Group AS

Oslo, 0161, Norway

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)