Infertility, MaleNCT06950203
The Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality
A study testing Very Long Chain Polyunsaturated Fatty Acids and Comparator arm (DHA) in people with Infertility, Male, run by Epax Norway AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Very Long Chain Polyunsaturated Fatty Acids and Comparator arm (DHA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 10 Mar 2025to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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) -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Medicus Group AS
Oslo, 0161
Steven Mansell, +47 12345678 ext. +47 12345678, information@medicus.com
About this study
Official title: A Randomised, Double Blinded Study to Determine the Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality in Healthy Men.
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.
Read the 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
- Being tested
- Very Long Chain Polyunsaturated Fatty Acids, Comparator arm (DHA)
- Keywords
- VLCFA, VLC-PUFA, Very long chain polyunsaturated fatty acids, fertility, supplement
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Long Chain Polyunsaturated Fatty AcidsDietary supplement
Fish oil with DHA and VLCPUFA
Comparator arm (DHA)Dietary supplement
Oil containing equal DHA content to active arm
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | DHA fish oil to match DHA content in active arm Receives: Dietary Supplement: Comparator arm (DHA) |
| VLC-PUFA | Experimental | EPAX EVOLVE 05 containing Very Long Chain Polyunsaturated Fatty Acids Receives: Dietary Supplement: Very Long Chain Polyunsaturated Fatty Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to end of intervention at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start10 Mar 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epax Norway AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950203
- Sponsor's protocol ID
- VLC 2024 01 Fertility
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data may be shared on request from relevant academics.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blinded Study to Determine the Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality in Healthy Men.
- ClinicalTrials.gov ID
- NCT06950203
- Acronym / sponsor ID
- VLC 2024 01 Fertility
- Conditions
- Infertility, Male
- Keywords
- VLCFA, VLC-PUFA, Very long chain polyunsaturated fatty acids, fertility, supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Epax Norway ASIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Dietary Supplement: Comparator arm (DHA)DHA fish oil to match DHA content in active arm |
| VLC-PUFA | Experimental | Dietary Supplement: Very Long Chain Polyunsaturated Fatty AcidsEPAX EVOLVE 05 containing Very Long Chain Polyunsaturated Fatty Acids |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
- Willing to refrain from omega-3/cod liver oil supplementation during the study. Use of other supplements is allowed.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very Long Chain Polyunsaturated Fatty AcidsFish oil with DHA and VLCPUFA | Dietary supplement | VLC-PUFA |
| Comparator arm (DHA)Oil containing equal DHA content to active arm | Dietary supplement | Placebo |
Primary outcome
Total Progressive Motile count will be measured pre- and post-intervention and compared to the comparator arm.
Time frame: From baseline to end of intervention at 3 months
The motile count will be performed by competent operators at each clinical site.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Yes. Anonymised data may be shared on request from relevant academics.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Long Chain Polyunsaturated Fatty Acids and Comparator arm (DHA) in people with Infertility, Male, run by Epax Norway AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Progressive Motile count will be measured pre- and post-intervention and compared to the comparator arm. (time frame: From baseline to end of intervention at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.