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

February 2, 2026 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lycopene
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
Capsule containing lycopene 7mg x 2 daily for 12 weeks
Placebo Comparator: Placebo
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
Capsule containing inactive substance 7mg x 2 daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

Manchester Metropolitan University
University of Sheffield
Health Education England, Wessex

Investigators

  • Principal Investigator: Lucy Wood, National Health Service, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH22299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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