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Male InfertilityPhase 2/3NCT05222841

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

A Phase 2/3 study testing Spermotrend in people with Male Infertility and Benign Prostatic Hyperplasia, run by Catalysis SL at 1 site in Nicaragua.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Spermotrend is a natural based product manufactured by Catalysis Laboratories. Its composition contains different essential elements for spermatogenesis: selenium, zinc and fructose. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Spermotrend
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteNicaragua
Study dates
15 Jun 2021to 15 Dec 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Nicaragua1 site

  • Clinica Seniors Managua

    Managua, 13035

About this study

Official title: The Effectiveness of the Spermotrend Food Supplement in the Treatment of Male Infertility and Benign Prostatic Hyperplasia

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.

Read more

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.
Read the detailed description

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.

Being tested
Spermotrend
Keywords
Antioxidant, spermatogenesis, Male infertility, Benign Prostatic Hyperplasia, Pygeum africanum
Medical subject headings
Infertility, Male, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpermotrendDietary supplement

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

Study groups in NCT05222841
Study groupRoleWhat they receive
SpermotrendExperimentalNot described
Receives: Dietary Supplement: Spermotrend

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sperm motility

    Evaluate the change in sperm motility by spermiogram.

    Measured: 3 months

  2. Sperm concentration

    Evaluate the changes in sperm concentration by spermiogram.

    Measured: 3 months

  3. Seminal fluid volume.

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

    Measured: 3 months

  4. Sperm morphology.

    Identify the changes in the sperm morphology by spermiogram.

    Measured: 3 months

  5. 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).

    Measured: 3 months

Secondary outcomes (7)

  1. Maintenance of semen quality in a normal range.

    Time of maintenance of the semen quality spermiogram analysis compared to the base line (weeks/months).

    Measured: 6 months

  2. Evaluation of the function of the urinary bladder and urethra

    Residual urine will be determined by urodynamic evaluation (Volume in mL).

    Measured: 3 months

  3. Evaluation of the function of the urinary bladder and urethra

    Urine flow rates (Qmax) will be determined by urodynamic evaluation (milliliters).

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: 3 months

  6. 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.

    Measured: 3 months

  7. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2022
  2. Study start15 Jun 2021
  3. Primary completion20 Jun 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05222841
Sponsor's protocol ID
SPT-NICA-2021
Status last verified
Jan 2023
First submitted
18 Oct 2021
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 19856162

  • 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.

    PubMed 33364208

  • 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.

    PubMed 34588319

  • 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.

    PubMed 28853101

  • 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.

    PubMed 30567310

  • 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.

    PubMed 33096823

  • 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.

    PubMed 33248336

  • 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.

    PubMed 31577095

  • 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.

    PubMed 30790614

  • 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.

    PubMed 31627963

  • 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.

    PubMed 17709901

  • 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.

    PubMed 25165780

  • 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.

    PubMed 22198631

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Spermotrend in people with Male Infertility and Benign Prostatic Hyperplasia, run by Catalysis SL at 1 site in Nicaragua.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nicaragua. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sperm motility (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05222841, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

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