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

NCT ID: NCT06950203

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-12-20

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.

Detailed Description

The study is a 2-armed, comparator controlled, double-blinded study. Subjects, study staff, sperm quality assessor and statistician will be blinded to the nutritional intervention.

The study Sponsor will be unblinded for purposes of packaging and supply of nutritional products.

Screening (Visit 0). Subjects will be asked to join the study based on an analysis documenting poor semen quality. Subjects will be informed about the result of the semen analysis and informed that the clinic is participating in a study about sperm quality. Subjects that show interest to participate will be verbally and in writing given further information about the study and the study procedures by dedicated study personnel. Patients willing to sign the consent will have the possibility to ask further questions. The clinic will provide a screening log with restricted access, containing screening number and subject identification.

Enrolment (Visit 1). For eligible subjects, the study coordinator will take the consent on behalf of the clinic.

Subjects who satisfy all inclusion criteria and no exclusion criteria will be randomised to investigational product or comparator and given a randomisation number and will receive enough capsules for 12 weeks. The clinic will provide a randomization log with non-identifiable information.

Telephone follow-up (Visit 2). After 6 weeks (± 1 week), a dedicated study nurse will contact the subject by phone. During the call, subjects will be asked about their well-being, whether they have been consistently taking their capsules, and if they are experiencing any issues that may be related to the study product.

Final Visit (Visit 3). 12 weeks (± 1 week) after the study commencement, the subject will attend a follow-up physical visit and return any remaining capsules.

Subjects will be examined for vital signs, physical examination, relevant medical history, current medications, smoking and alcohol habits and a food frequency questionnaire. A period of abstinence (2 days) will be requested prior to study specific sperm samples.

Each subject will take 2 x 1.0g capsules of EVOLVE 05 daily for 3 months or 2 x 1.0g comparator capsules.

Sperm samples for quality measurements will be taken at visit 1 and visit 3. The remaining sample will be frozen and maintained for analysis of VLCFA content.

Dietary intake will be recorded to control for marine specific dietary variables: Assessment at visit 1 and visit 3 using a brief questionnaire.

Conditions

Infertility, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

DHA fish oil to match DHA content in active arm

Group Type: ACTIVE_COMPARATOR

Comparator arm (DHA)

Intervention Type: DIETARY_SUPPLEMENT

Oil containing equal DHA content to active arm

VLC-PUFA

EPAX EVOLVE 05 containing Very Long Chain Polyunsaturated Fatty Acids

Group Type: EXPERIMENTAL

Very Long Chain Polyunsaturated Fatty Acids

Intervention Type: DIETARY_SUPPLEMENT

Fish oil with DHA and VLCPUFA

Interventions

Very Long Chain Polyunsaturated Fatty Acids

Fish oil with DHA and VLCPUFA

Intervention Type: DIETARY_SUPPLEMENT

Comparator arm (DHA)

Oil containing equal DHA content to active arm

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Men aged 18-55

2. Referred for or claiming a semen analysis.

3. Willing to have at least 2 days abstinence of sexual activity prior to a sperm sample being taken.

4. Reduced semen quality defined as:

• Progressive motility: <30%

5. Willing to refrain from omega-3/cod liver oil supplementation during the study. Use of other supplements is allowed.

-

Exclusion Criteria

1. Known allergy to fish products

2. Historically, known, or suspected bacterial infection in reproductive organs

3. Varicocele suspected from physical examination

4. Azoospermia

5. Diagnosis of diabetes (type 2)

6. Diagnosis of Crohn´s Disease

7. Inferior semen quality due to medical reasons, such as cryptorchidism (via questionnaire/medical records) -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Epax Norway AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medicus Group AS

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Facility Contacts

Steven Mansell

Role: primary

information@medicus.com

+47 12345678 ext. +47 12345678

Other Identifiers

VLC 2024 01 Fertility

Identifier Type: -

Identifier Source: org_study_id