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

Study Overview
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Brief Summary
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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 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
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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.

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

Conditions
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Male Infertility, Benign Prostatic Hyperplasia, Spermatogenesis and Semen Disorders

Intervention / Treatment
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* Dietary Supplement: Spermotrend


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spermotrend<br> | Dietary Supplement: Spermotrend<br>* Patients who are treated with Spermotrend (536,62g) are given 3 capsules every day for 3 months, taken orally every 8 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antioxidant, spermatogenesis, Male infertility, Benign Prostatic Hyperplasia, Pygeum africanum