Clinical trial NCT05222841: The Effectiveness of Spermotrend Food Supplement in the Treatment of Male Infertility
Official title: The Effectiveness of the Spermotrend Food Supplement in the Treatment of Male Infertility and Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Male Infertility
Benign Prostatic Hyperplasia
Spermatogenesis and Semen Disorders
Keywords: Antioxidant
spermatogenesis
Male infertility
Benign Prostatic Hyperplasia
Pygeum africanum
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sperm motility
timeFrame: 3 months
measure: Sperm concentration
timeFrame: 3 months
measure: Seminal fluid volume.
timeFrame: 3 months
measure: Sperm morphology.
timeFrame: 3 months
measure: Incidence of adverse events during the treatment with Spermotrend
timeFrame: 3 months
Secondary outcomes:
measure: Maintenance of semen quality in a normal range.
timeFrame: 6 months
measure: Evaluation of the function of the urinary bladder and urethra
timeFrame: 3 months
measure: Evaluation of the function of the urinary bladder and urethra
timeFrame: 3 months
measure: Clinical evoluation of Benign prostatic hyperplasia
timeFrame: 3 months
measure: Evaluation of urinary symptoms related with benign prostatic hyperplasia
timeFrame: 3 months
measure: Prostate size in patients with benign prostatic hyperplasia
timeFrame: 3 months
measure: Varicocele Degree
timeFrame: 3 months
Other outcomes:
Locations:
city: Managua
country: Nicaragua
facility: Clinica Seniors Managua
Study officials:
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