A Randomised Placebo-controlled Trial to Investigate the Effect of Lactolycopene on Sperm Quality in Men With a Low Total Motile Sperm Count: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Total motile sperm count
研究概览
简要总结
The goal of this clinical trial is to test whether lycopene (an antioxidant found in cooked tomatoes) will improve the number of swimming sperm in the ejaculates of men with low total motile sperm count.
Participants will take either lycopene capsules or identical capsules containing no lycopene for 12 weeks. We will analyse the quality of their semen before and after taking the capsules, and compare the results.
Hypothesis: Supplementation with lycopene will improve testicular function (semen quality) in males with low total motile sperm count (TMSC).
详细描述
Impaired testicular function contributes to around 50% of heterosexual infertility and is often characterized by a low total motile sperm count. Evidence suggests that one cause of low total motile sperm count is oxidative stress within the ejaculate, where harmful oxygen species damage the sperm. Antioxidants to combat oxidative stress within the ejaculate have been proposed as a method of increasing the total motile sperm count. Lycopene is a powerful antioxidant found abundantly in cooked tomatoes and has been shown to improve testicular function in a healthy population. This double blinded randomised controlled trial aims to investigate whether lycopene can improve testicular output in participants with a low motile sperm count. Semen analysis will be carried out before and after the intervention. The intervention is a commercially available lycopene capsule or an identical placebo.
Hypothesis
Supplementation with lactolycopene will improve testicular function (semen quality) in males with low total motile sperm count (TMSC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 18 - 50 years of age
- •Attending the Fertility Clinic at the Jessop Wing, (Sheffield Teaching Hospitals).
- •Found to have poor testicular function as evidenced by a low motile sperm count (<20 million motile sperm per ejaculate).
- •Willing to comply with the study procedures and provide informed consent.
排除标准
- •Participants who report allergy to tomatoes, whey, soy.
- •Men with previous testicular surgery or a current or previous diagnosis of cancer.
- •Men found to have normal sperm parameters.
- •Known infection with hepatitis or HIV.
- •Men with azoospermia
研究组 & 干预措施
Lycopene
Capsules containing 7mg of lycopene. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to placebo capsule.
干预措施: Lycopene (Dietary Supplement)
Placebo
Placebo capsules containing an inactive ingredient. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to lycopene capsule.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Total motile sperm count
时间窗: Change from Baseline total motile sperm count at 12 weeks
Number of swimming sperm in the total ejaculate
次要结局
- Sperm motility(Change from Baseline sperm motility at 12 weeks)
- Sperm DNA fragmentation(Change from Baseline sperm DNA fragmentation at 12 weeks)
- Sperm concentration(Change from Baseline sperm concentration at 12 weeks)
- Sperm morphology(Change from Baseline sperm morphology at 12 weeks)
- Oxidative reductive potential of semen(Change from Baseline semen oxidative reductive potential at 12 weeks)