The Effectiveness of the Spermotrend Food Supplement in the Treatment of Male Infertility and Benign Prostatic Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Sperm motility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males over
- •Patient who shows alterations of the spermatogenesis and/or benign prostatic hyperplasia.
- •Patients without testicular pathology.
- •Serology and HIV negative.
- •Signed informed consent.
排除标准
- •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.
结局指标
主要结局
Sperm motility
时间窗: 3 months
Evaluate the change in sperm motility by spermiogram.
Sperm concentration
时间窗: 3 months
Evaluate the changes in sperm concentration by spermiogram.
Seminal fluid volume.
时间窗: 3 months
To identify the changes in the seminal fluid volume by spermiogram.
Sperm morphology.
时间窗: 3 months
Identify the changes in the sperm morphology by spermiogram.
Incidence of adverse events during the treatment with Spermotrend
时间窗: 3 months
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).
次要结局
- Maintenance of semen quality in a normal range.(6 months)
- Clinical evoluation of Benign prostatic hyperplasia(3 months)
- Evaluation of urinary symptoms related with benign prostatic hyperplasia(3 months)
- Prostate size in patients with benign prostatic hyperplasia(3 months)
- Varicocele Degree(3 months)
- Evaluation of the function of the urinary bladder and urethra(3 months)