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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Omega 3 Fats on Sperm Quality and Sexual Function

NCT00406874

Infertility

TERMINATED PHASE2

Effect of Antioxidant Probiotic Administration on Seminal Quality and Reproductive Outcomes.

NCT04585984

Male Infertility

COMPLETED NA

Supplementation for Male Subfertility

NCT06091969

Male Infertility

NOT_YET_RECRUITING PHASE2

A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers

NCT01595308

Male Infertility

COMPLETED PHASE1

Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results

NCT05951075

Spermatogenesis and Semen Disorders Infertility, Male

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Total Motile Sperm Count

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lycopene

Capsules containing 7mg of lycopene. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to placebo capsule.

Group Type EXPERIMENTAL

Lycopene

Intervention Type DIETARY_SUPPLEMENT

Capsule containing lycopene 7mg x 2 daily for 12 weeks

Placebo

Placebo capsules containing an inactive ingredient. 2 capsules are swallowed once per day with water for 12 weeks. Looks identical to lycopene capsule.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lycopene

Capsule containing lycopene 7mg x 2 daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No