Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-01 @ 12:20 PM
Study NCT ID:
NCT06950203
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality
Sponsor:
Epax Norway AS
Organization:
Study Overview
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.
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: