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

NCT05671562 | Completed

• 1 other identifier: STH22299
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Total Motile Sperm Count

Outcome Measures

Primary Outcomes (1)

• Total motile sperm count

  Number of swimming sperm in the total ejaculate

  Change from Baseline total motile sperm count at 12 weeks

Secondary Outcomes (5)

• Sperm motility

  Change from Baseline sperm motility at 12 weeks

• Sperm concentration

  Change from Baseline sperm concentration at 12 weeks

• Sperm morphology

  Change from Baseline sperm morphology at 12 weeks

• Sperm DNA fragmentation

  Change from Baseline sperm DNA fragmentation at 12 weeks

• Oxidative reductive potential of semen

  Change from Baseline semen oxidative reductive potential at 12 weeks

Study Arms (2)

Lycopene

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Lycopene DIETARY_SUPPLEMENT

Capsule containing lycopene 7mg x 2 daily for 12 weeks

Lycopene

Placebo DIETARY_SUPPLEMENT

Capsule containing inactive substance 7mg x 2 daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Health Education England, Wessex: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Manchester Metropolitan University: collaborator
• University of Sheffield: collaborator

Study Sites (1)

Jessop Fertility

Sheffield, United Kingdom

Location

MeSH Terms

Interventions

Lycopene

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Lucy Wood

  National Health Service, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 4, 2023
• Study Start: May 3, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)