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NCT05222841
The Effectiveness of Spermotrend Food Supplement in the Treatment of Male Infertility
Phase 2, PHASE3 trial testing Spermotrend in Male Infertility in 150 participants. Completed in 15 December 2022.
20 June 2022
Quick facts
| Lead sponsor | Catalysis SL |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 15 June 2021 |
| Primary completion | 20 June 2022 |
| Estimated completion | 15 December 2022 |
| Sites | 1 location across Nicaragua |
Drugs / interventions tested
- Spermotrend
Conditions studied
- Male Infertility — all drugs for Male Infertility →
- Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
- Spermatogenesis and Semen Disorders — all drugs for Spermatogenesis and Semen Disorders →
Sponsor
Catalysis SL — full company profile →
Who can join
18 and older, male only, with Male Infertility or Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05222841
- Europe PMC full search
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Related trials
Other trials of Spermotrend
Trials testing the same drug.
- NCT04256278 — Administration of Antioxidants to Infertile Men and Sperm Quality · NA · completed
Other recruiting trials for Male Infertility
Currently open trials in the same condition.
- NCT07375238 — Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress · NA · recruiting
- NCT07369362 — To Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That · NA · active not recruiting
- NCT06956287 — The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility · NA · recruiting
- NCT06561451 — Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia · NA · recruiting
- NCT07056400 — Trial to Improve Fertilization Rate and Embryo Development in Intracytoplasmic Sperm Injection (ICSI) Cycles · NA · active not recruiting
Other Catalysis SL trials
Trials by the same sponsor.
- NCT07179237 — Efficacy of Carminal in Helicobacter Pylori Gastritis · Phase 2 · recruiting
- NCT06363201 — Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumour · NA · not yet recruiting
- NCT05916911 — Evaluation Of The Efficacy Of The Combination Of GLIZIGEN® Oral Solution 1/Day And Vaginal Gel 1/Night For 2 Months In P · Phase 4 · unknown
- NCT06496087 — Evaluation of DEPREXIL in Patients With Clinical Depression Through Psychological and Neuroendocrine Assessment · NA · completed
- NCT06361992 — Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05222841 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Catalysis SL
- Last refreshed: 28 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05222841.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing