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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
SECONDARY OBJECTIVES
Every day, all over the world, increasingly more couples have to go to specialised centres in the hope of solving their infertility problems. In the past, female infertility was thought to be the main cause of this problem, but in the course of time, those of us who work in the field of Gynaecology, which is such a delicate issue, are convinced that the initial statistics concerning the prevalence of infertility in women is now just pure myth. The male factor is the main cause of infertility in numerous couples that go to the doctor every day, the percentage of which surpasses that of female infertility in many places. Not everyone have access to the high-tech assisted reproduction techniques which compensate for any spermatogenesis. Many studies have been carried out in the hope of improving the sperm quality in men. Antioxidants play an important role in the spermiogenesis, but so far no product has been found that really meets the expectations of improving the spermatogenesis in the short term. A product that naturally or through low- tech assisted reproduction techniques improves the pregnancy rates among couples that suffer from this type of disorder.
Catalysis Laboratories is specialized in natural antioxidant products as adjuvants and alternative treatments for prevention, management and recovery from different diseases.
The aim of this clinical trial is to study the efficacy and safety of Spermotrnend, a natural product manufactured by Catalysis Laboratories, in the improvement of sperm's quality and quantity in male infertility as well as in urinary symptoms and varicocele in those patients who suffer it in association or not with infertility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spermotrend | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of semen quality in a normal range. | Time of maintenance of the semen quality spermiogram analysis compared to the base line (weeks/months). | 6 months |
| Evaluation of the function of the urinary bladder and urethra |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Seniors Managua | Managua | 13035 | Nicaragua |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19856162 | Background | 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. | |
| 33364208 | 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. |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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Residual urine will be determined by urodynamic evaluation (Volume in mL).
| 3 months |
| Evaluation of the function of the urinary bladder and urethra | Urine flow rates (Qmax) will be determined by urodynamic evaluation (milliliters). | 3 months |
| Clinical evoluation of Benign prostatic hyperplasia | To evaluate the urinary symptoms related with benign prostatic hyperplasia by blood analysis: AUA guideline prostate-specific antigen (PSA) and serum creatinine measurements will be measured to evaluate the benign prostatic hyperplasia . Serum PSA level should be determined in men in the BPH age group, preferably before the rectal examination. A careful history taking and physical examination will usually identify patients at risk for bleeding tendencies. | 3 months |
| Evaluation of urinary symptoms related with benign prostatic hyperplasia | To evaluate the urinary symptoms related with benign prostatic hyperplasia by the specific questionnaire International Prostate Symptom Score (IPSS). Answers will be scored from 0=Not at all; 1= Less than 1 time in 5; 2=Less than half of time; 3= About Half of time; 4=More than half of time; to 5= Almost always. (For example: - How often have you haf the sensation of not emptying your bladder completely after you finished urinating? From 0 to 5). The summatory of symptom scores will be evaluated as 1-7 mild symptoms; 8-19 moderate symptoms; and 20-35 severe symptoms. | 3 months |
| Prostate size in patients with benign prostatic hyperplasia | To evaluate the benign prostatic hyperplasia volume by image analysis with ultrasound. Residual urine and urine flow rates will be determined by urodynamic evaluation. | 3 months |
| Varicocele Degree | To evaluate varicocele degree (1, 2 or 3) in term of size and its evolution in male infertility from the base line to the end of the treatment with Spermotrend. | 3 months |
| 34588319 | 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. |
| 28853101 | 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. |
| 30567310 | 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. |
| 33096823 | 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. |
| 33248336 | 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. |
| 31577095 | 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. |
| 30790614 | 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. |
| 31627963 | 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. |
| 17709901 | 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. |
| 25165780 | 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. |
| 22198631 | 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. |
| D052801 |
| Male Urogenital Diseases |
| D011469 | Prostatic Diseases |