Clinical trial NCT05671562: The Effect of Lycopene on Sperm Quality in Men Attending Fertility Clinic
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Total Motile Sperm Count
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Health Education England, Wessex
name: Manchester Metropolitan University
name: University of Sheffield
First posted: 2023-01-04
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Total motile sperm count
timeFrame: Change from Baseline total motile sperm count at 12 weeks
Secondary outcomes:
measure: Sperm motility
timeFrame: Change from Baseline sperm motility at 12 weeks
measure: Sperm concentration
timeFrame: Change from Baseline sperm concentration at 12 weeks
measure: Sperm morphology
timeFrame: Change from Baseline sperm morphology at 12 weeks
measure: Sperm DNA fragmentation
timeFrame: Change from Baseline sperm DNA fragmentation at 12 weeks
measure: Oxidative reductive potential of semen
timeFrame: Change from Baseline semen oxidative reductive potential at 12 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Jessop Fertility
Study officials:
affiliation: National Health Service, United Kingdom
name: Lucy Wood
role: PRINCIPAL_INVESTIGATOR
References: