The Effect of Lycopene on Sperm Quality in Men Attending Fertility Clinic
- Conditions
- Total Motile Sperm Count
- Interventions
- Dietary Supplement: LycopeneDietary Supplement: Placebo
- Registration Number
- NCT05671562
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lycopene Lycopene Capsules containing 7mg of lycopene. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to placebo capsule. Placebo Placebo Placebo capsules containing an inactive ingredient. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to lycopene capsule.
- Primary Outcome Measures
Name Time Method Total motile sperm count Change from Baseline total motile sperm count at 12 weeks Number of swimming sperm in the total ejaculate
- Secondary Outcome Measures
Name Time Method Sperm motility Change from Baseline sperm motility at 12 weeks % of swimming sperm
Sperm DNA fragmentation Change from Baseline sperm DNA fragmentation at 12 weeks % of sperm with fragmented DNA
Sperm concentration Change from Baseline sperm concentration at 12 weeks Number of sperm per ml of ejaculate
Sperm morphology Change from Baseline sperm morphology at 12 weeks Appearance of sperm
Oxidative reductive potential of semen Change from Baseline semen oxidative reductive potential at 12 weeks To compare level of oxidants and antioxidants within the sample
Trial Locations
- Locations (1)
Jessop Fertility
🇬🇧Sheffield, United Kingdom