CompletedPhase 2/3

The Effectiveness of Spermotrend Food Supplement in the Treatment of Male Infertility

Nicaragua150 participantsStarted 2021-06-15

Plain-language summary

Spermotrend is a natural based product manufactured by Catalysis Laboratories. Its composition contains different essential elements for spermatogenesis: selenium, zinc and fructose. In addition, it contains L-arginine, natural precursor of nitric oxide that favors vasodilation, and pygeum africanum extract with antioxidant, antiinflammatory, antiandrogenic and antiproliferative action. Its main action resides in the control of oxidative damage to the tissues of the male reproductive system, as well as the control of correct spermatogenesis. Given that sperm quality can be altered by oxidative stress and that male infertility affects more and more people, the prevention and management of this deterioration becomes increasingly important. Therefore, to evaluate Spermotrend as a new therapy for male infertility, the investigators are going to study the safety and efficacy of this treatment in this clinical trial. RESEARCH HYPOTHESIS The treatment with Spermotrend improves the parameters of the spermatogenesis. GENERAL OBJECTIVES To evaluate the effectiveness and the safety level of the natural Spermotrend product in the treatment of male infertility. SPECIFIC OBJECTIVES * Evaluate the increase in sperm motility and concentration. * Identify the improvement in the seminal fluid volume. * Identify the positive changes in the sperm morphology. * Determine how to maintain the semen analysis in a normal range. * Describe the adverse effects. SECONDARY OBJECTIVES * Identify the improvement in urinary symptoms related with benign prostatic hyperplasia. * Identify the improvement in varicocele.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males over 18. * Patient who shows alterations of the spermatogenesis and/or benign prostatic hyperplasia. * Patients without testicular pathology. * Serology and HIV negative. * Signed informed consent. Exclusion Criteria: * Patients with associated pathologies: epididymo-orchitis, radiation or chemotherapy. * Patients with a testicular pathology that has been resolved. * Patients with non-transmissible chronic pathologies. * Patients who have not agreed to take part in the study. * Patients that are undergoing antioxidant treatment or who have completed this treatment in the last six months. * Patients who are being treated with vitamins or who have completed this treatment in the last six months. * Patients that are being treated with anti-inflammatory medications or who have completed this treatment in the last six months. * Patients who are undergoing hormone treatment prescribed for andrology or who have completed this treatment in the last six months. * Patients with serology or who are HIV positive.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sperm motility

Timeframe: 3 months

Sperm concentration

Timeframe: 3 months

Seminal fluid volume.

Timeframe: 3 months

Sperm morphology.

Timeframe: 3 months

Incidence of adverse events during the treatment with Spermotrend

Timeframe: 3 months

Trial details

NCT IDNCT05222841

SponsorCatalysis SL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-20

View on ClinicalTrials.gov More Male Infertility trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.