Total Motile Sperm Count
Conditions
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).
Interventions
DIETARY_SUPPLEMENTLycopene
Capsule containing lycopene 7mg x 2 daily for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Capsule containing inactive substance 7mg x 2 daily for 12 weeks
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Health Education England, Wessex
Manchester Metropolitan University
University of Sheffield
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Males aged 18 - 50 years of age 2. Attending the Fertility Clinic at the Jessop Wing, (Sheffield Teaching Hospitals). 3. Found to have poor testicular function as evidenced by a low motile sperm count (\<20 million motile sperm per ejaculate). 4. Willing to comply with the study procedures and provide informed consent.
Exclusion criteria
1. Participants who report allergy to tomatoes, whey, soy. 2. Men with previous testicular surgery or a current or previous diagnosis of cancer. 3. Men found to have normal sperm parameters. 4. Known infection with hepatitis or HIV. 5. Men with azoospermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total motile sperm count | Change from Baseline total motile sperm count at 12 weeks | Number of swimming sperm in the total ejaculate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sperm motility | Change from Baseline sperm motility at 12 weeks | % of swimming sperm |
| 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 |
| Sperm DNA fragmentation | Change from Baseline sperm DNA fragmentation at 12 weeks | % of sperm with fragmented DNA |
| 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 |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORLucy Wood
National Health Service, United Kingdom
Outcome results
None listed