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

Last updated: March 3, 2025
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Lycopene

Placebo

Clinical Study ID

NCT05671562
STH22299
  • Ages 18-50
  • Male

Study 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).

Eligibility Criteria

Inclusion

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 (<20million motile sperm per ejaculate).

  4. Willing to comply with the study procedures and provide informed consent.

Exclusion

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

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Lycopene
Phase:
Study Start date:
May 03, 2023
Estimated Completion Date:
December 31, 2025

Study 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).

Connect with a study center

  • Jessop Fertility

    Sheffield,
    United Kingdom

    Site Not Available

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