A Randomised, Double Blinded Study to Determine the Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality in Healthy Men.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Total Progressive Motile count will be measured pre- and post-intervention and compared to the comparator arm.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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) -
结局指标
主要结局
Total Progressive Motile count will be measured pre- and post-intervention and compared to the comparator arm.
时间窗: From baseline to end of intervention at 3 months
The motile count will be performed by competent operators at each clinical site.
次要结局
未报告次要终点