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

NHS Foundation Trust

Status: Active, not recruiting

Conditions: Total Motile Sperm Count

Treatments: Dietary Supplement: Lycopene; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05671562

STH22299

Details and patient eligibility

About

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).

Full 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).

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Lycopene

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lycopene

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo