Total Motile Sperm CountNCT05671562
The Effect of Lycopene on Sperm Quality in Men Attending Fertility Clinic
A study testing Lycopene in people with Total Motile Sperm Count, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Total Motile Sperm Count
- What is being tested?
- Lycopene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 May 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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).
- Conditions
- Total Motile Sperm Count
- Being tested
- Lycopene, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LycopeneDietary supplement
Capsule containing lycopene 7mg x 2 daily for 12 weeks
PlaceboDietary supplement
Capsule containing inactive substance 7mg x 2 daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lycopene | Experimental | Capsules containing 7mg of lycopene. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to placebo capsule. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total motile sperm count
Number of swimming sperm in the total ejaculate
Measured: Change from Baseline total motile sperm count at 12 weeks
Secondary outcomes (5)
Sperm motility
% of swimming sperm
Measured: Change from Baseline sperm motility at 12 weeks
Sperm concentration
Number of sperm per ml of ejaculate
Measured: Change from Baseline sperm concentration at 12 weeks
Sperm morphology
Appearance of sperm
Measured: Change from Baseline sperm morphology at 12 weeks
Sperm DNA fragmentation
% of sperm with fragmented DNA
Measured: Change from Baseline sperm DNA fragmentation at 12 weeks
Oxidative reductive potential of semen
To compare level of oxidants and antioxidants within the sample
Measured: Change from Baseline semen oxidative reductive potential at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start3 May 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Motile Sperm CountStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Health Education England, Wessex, Manchester Metropolitan University, University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Lucy Wood, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671562
- Sponsor's protocol ID
- STH22299
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2022
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05671562
- Acronym / sponsor ID
- STH22299
- Conditions
- Total Motile Sperm Count
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Health Education England, Wessex, Manchester Metropolitan University, University of Sheffield
- Study start
- 3 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lycopene | Experimental | Dietary Supplement: LycopeneCapsules containing 7mg of lycopene. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to placebo capsule. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules containing an inactive ingredient. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to lycopene capsule. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LycopeneCapsule containing lycopene 7mg x 2 daily for 12 weeks | Dietary supplement | Lycopene |
| PlaceboCapsule containing inactive substance 7mg x 2 daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Total motile sperm count
Time frame: Change from Baseline total motile sperm count at 12 weeks
Number of swimming sperm in the total ejaculate
5 secondary outcomes
Sperm motility
Time frame: Change from Baseline sperm motility at 12 weeks
Sperm concentration
Time frame: Change from Baseline sperm concentration at 12 weeks
Sperm morphology
Time frame: Change from Baseline sperm morphology at 12 weeks
Sperm DNA fragmentation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Total Motile Sperm Count
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Wood principal investigator
National Health Service, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycopene in people with Total Motile Sperm Count, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total motile sperm count (time frame: Change from Baseline total motile sperm count at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.