The Effect of Lycopene on Sperm Quality in Men Attending Fertility Clinic

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Total Motile Sperm Count

Intervention / Treatment
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* Dietary Supplement: Lycopene
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lycopene<br>Capsules containing 7mg of lycopene. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to placebo capsule. | Dietary Supplement: Lycopene<br>* Capsule containing lycopene 7mg x 2 daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo capsules containing an inactive ingredient. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to lycopene capsule. | Dietary Supplement: Placebo<br>* Capsule containing inactive substance 7mg x 2 daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total motile sperm count | Number of swimming sperm in the total ejaculate | Change from Baseline total motile sperm count at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm motility | % of swimming sperm | Change from Baseline sperm motility at 12 weeks | 
| Sperm concentration | Number of sperm per ml of ejaculate | Change from Baseline sperm concentration at 12 weeks | 
| Sperm morphology | Appearance of sperm | Change from Baseline sperm morphology at 12 weeks | 
| Sperm DNA fragmentation | % of sperm with fragmented DNA | Change from Baseline sperm DNA fragmentation at 12 weeks | 
| Oxidative reductive potential of semen | To compare level of oxidants and antioxidants within the sample | Change from Baseline semen oxidative reductive potential at 12 weeks |