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

NCT05222841 | Completed Phase 2

• 1 other identifier: SPT-NICA-2021
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Male Infertility; Benign Prostatic Hyperplasia; Spermatogenesis and Semen Disorders

Keywords

Antioxidant; spermatogenesis; Male infertility; Benign Prostatic Hyperplasia; Pygeum africanum

Outcome Measures

Primary Outcomes (5)

• Sperm motility

  Evaluate the change in sperm motility by spermiogram.

  3 months

• Sperm concentration

  Evaluate the changes in sperm concentration by spermiogram.

  3 months

• Seminal fluid volume.

  To identify the changes in the seminal fluid volume by spermiogram.

  3 months

• Sperm morphology.

  Identify the changes in the sperm morphology by spermiogram.

  3 months

• Incidence of adverse events during the treatment with Spermotrend

  To study and asses any adverse event related with the product assay in patients with male infertility, measured by means of a bimonthly personal questionnaire: nausea, vomiting, digestive pain, stomach ache... (mild, moderate, severe, yes or no).

  3 months

Secondary Outcomes (7)

• Maintenance of semen quality in a normal range.

  6 months

• Evaluation of the function of the urinary bladder and urethra

  3 months

• Evaluation of the function of the urinary bladder and urethra

  3 months

• Clinical evoluation of Benign prostatic hyperplasia

  3 months

• Evaluation of urinary symptoms related with benign prostatic hyperplasia

  3 months

Study Arms (1)

Spermotrend

EXPERIMENTAL

Dietary Supplement: Spermotrend

Interventions

Spermotrend DIETARY_SUPPLEMENT

Patients who are treated with Spermotrend (536,62g) are given 3 capsules every day for 3 months, taken orally every 8 hours.

Spermotrend

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

Clinica Seniors Managua

Managua, 13035, Nicaragua

Location

Related Publications (13)

• Boitani C, Puglisi R. Selenium, a key element in spermatogenesis and male fertility. Adv Exp Med Biol. 2008;636:65-73. doi: 10.1007/978-0-387-09597-4_4.

  PMID: 19856162 BACKGROUND

• H B, A S, A J, P A, B S, D S, A EM, M N. Radioprotective Effects of Zinc and Selenium on Mice Spermatogenesis. J Biomed Phys Eng. 2020 Dec 1;10(6):707-712. doi: 10.31661/jbpe.v0i0.957. eCollection 2020 Dec.

  PMID: 33364208 BACKGROUND

• Naderi M, Ahangar N, Badakhshan F, Ghasemi M, Shaki F. Zinc and selenium supplement mitigated valproic acid-induced testis toxicity by modulating the oxidative redox balance in male rats. Anat Cell Biol. 2021 Sep 30;54(3):387-394. doi: 10.5115/acb.20.280.

  PMID: 34588319 BACKGROUND

• Irani M, Amirian M, Sadeghi R, Lez JL, Latifnejad Roudsari R. The Effect of Folate and Folate Plus Zinc Supplementation on Endocrine Parameters and Sperm Characteristics in Sub-Fertile Men: A Systematic Review and Meta-Analysis. Urol J. 2017 Aug 29;14(5):4069-4078.

  PMID: 28853101 BACKGROUND

• Kerns K, Zigo M, Sutovsky P. Zinc: A Necessary Ion for Mammalian Sperm Fertilization Competency. Int J Mol Sci. 2018 Dec 18;19(12):4097. doi: 10.3390/ijms19124097.

  PMID: 30567310 BACKGROUND

• Allouche-Fitoussi D, Breitbart H. The Role of Zinc in Male Fertility. Int J Mol Sci. 2020 Oct 21;21(20):7796. doi: 10.3390/ijms21207796.

  PMID: 33096823 BACKGROUND

• Madej D, Pietruszka B, Kaluza J. The effect of iron and/or zinc diet supplementation and termination of this practice on the antioxidant status of the reproductive tissues and sperm viability in rats. J Trace Elem Med Biol. 2021 Mar;64:126689. doi: 10.1016/j.jtemb.2020.126689. Epub 2020 Nov 19.

  PMID: 33248336 BACKGROUND

• Cicero AFG, Allkanjari O, Busetto GM, Cai T, Largana G, Magri V, Perletti G, Robustelli Della Cuna FS, Russo GI, Stamatiou K, Trinchieri A, Vitalone A. Nutraceutical treatment and prevention of benign prostatic hyperplasia and prostate cancer. Arch Ital Urol Androl. 2019 Oct 2;91(3). doi: 10.4081/aiua.2019.3.139.

  PMID: 31577095 BACKGROUND

• Santos HO, Howell S, Teixeira FJ. Beyond tribulus (Tribulus terrestris L.): The effects of phytotherapics on testosterone, sperm and prostate parameters. J Ethnopharmacol. 2019 May 10;235:392-405. doi: 10.1016/j.jep.2019.02.033. Epub 2019 Feb 18.

  PMID: 30790614 BACKGROUND

• Salinas-Casado J, Esteban-Fuertes M, Carballido-Rodriguez J, Cozar-Olmo JM. Review of the experience and evidence of Pygeum africanum in urological practice. Actas Urol Esp (Engl Ed). 2020 Jan-Feb;44(1):9-13. doi: 10.1016/j.acuro.2019.08.002. Epub 2019 Oct 16. English, Spanish.

  PMID: 31627963 BACKGROUND

• Shenouda NS, Sakla MS, Newton LG, Besch-Williford C, Greenberg NM, MacDonald RS, Lubahn DB. Phytosterol Pygeum africanum regulates prostate cancer in vitro and in vivo. Endocrine. 2007 Feb;31(1):72-81. doi: 10.1007/s12020-007-0014-y.

  PMID: 17709901 BACKGROUND

• Pagano E, Laudato M, Griffo M, Capasso R. Phytotherapy of benign prostatic hyperplasia. A minireview. Phytother Res. 2014 Jul;28(7):949-55. doi: 10.1002/ptr.5084.

  PMID: 25165780 BACKGROUND

• Larre S, Camparo P, Comperat E, Boulbes D, Haddoum M, Baulande S, Soularue P, Costa P, Cussenot O. Biological effect of human serum collected before and after oral intake of Pygeum africanum on various benign prostate cell cultures. Asian J Androl. 2012 May;14(3):499-504. doi: 10.1038/aja.2011.132. Epub 2011 Dec 26.

  PMID: 22198631 BACKGROUND

MeSH Terms

Conditions

Infertility, Male; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Prostatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: February 3, 2022
• Study Start: June 15, 2021
• Primary Completion: June 20, 2022
• Study Completion: December 15, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

NI (1)