Evaluation of Treatment With Trans-resveratrol, Folic Acid, Vitamin D, Vitamin B12 and B6 in Men With Infertility
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline Vitality at 1 month
研究概览
简要总结
The objective of this study is to evaluate the impact of the Genante(TM) on the spermiogram parameters in infertile male patients
详细描述
This is a single-centre prospective observational study. Twenty infertile male patients.
Inclusion criteria are:
Age:18-50 years oligozoospermia: < 5 million spermatozoa/mL; asthenozoospermia: < 32% progressive motile spermatozoa; teratozoospermia: < 4% normal forms.
Esclusion criteria:
Patients with azoospermia, who smoke, use drugs, drugs with proven fertility toxicity, exposed to any environmental or occupational toxic substances, radiation or heat; with orchitis secondary to mumps, sexually transmitted diseases, history of cryptorchidism, previous testicular torsion, genitourinary anomalies, alterations of the epididymis or deferens; and inguinal surgery
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male 18-50 years
- •oligozoospermia: < 5 million spermatozoa/mL;
- •asthenozoospermia: < 32% progressive motile spermatozoa;
- •teratozoospermia: < 4% normal forms.
排除标准
- •azoospermia
- •use drugs
- •use drugs with proven fertility toxicity
- •exposition to any environmental or occupational toxic substances
- •exposition to radiation or heat
- •orchitis secondary to mumps
- •sexually transmitted diseases
- •history of cryptorchidism
- •previous testicular torsion
- •genitourinary anomalies
- •alterations of the epididymis or deferens
- •inguinal surgery
研究组 & 干预措施
Genante (Tm)
Genante tablets One tablet in the morning and one tablet in the evening for 3 months
干预措施: Genante (Dietary Supplement)
结局指标
主要结局
Change from baseline Vitality at 1 month
时间窗: 1 month
live spermatozoa
Change from baseline Prolactina at 1 month
时间窗: 1 month
plasmatic evaluation of prolactina
Change from baseline Trans rectal Prostatic ultrasound at 1 month
时间窗: 1 month
prostate volume and morphology by ultrasound
Change from baseline estradiol at 1 month
时间窗: 1 month
plasmatic evaluation of esatrdiol
Change from baseline 25-OH-Vitamin D3 at 1 month
时间窗: 1 month
plasmatic evaluation of 25-OH-Vitamin D3
Change from 1 month 25-OH-Vitamin D3 at 6 months
时间窗: 6 months
plasmatic evaluation of 25-OH-Vitamin D3
Change from baseline Scrotal ultrasound at 1 month
时间窗: 1 month
testis volume and vas deferens by ultrasound
Change from 1 month Scrotal ultrasound at 6 months
时间窗: 6 months
testis volume and vas deferens by ultrasound
Change from 1 month Trans rectal Prostatic ultrasound at 6 months
时间窗: 6 months
prostate volume and morphology by ultrasound
Change from 1 month estradiol at 6 months
时间窗: 6 months
plasmatic evaluation of esatrdiol
Change from Baseline Semen volume at 1 month
时间窗: 1 month
semen volume in semen analysis
Change from 1month Semen volume at 6 months
时间窗: 6 months
semen volume in semen analysis
Change from baseline Total sperm number at 1 month
时间窗: 1 month
total sperm number in semen analysis
Change from 1 month Total sperm number at 6 months
时间窗: 6 months
total sperm number in semen analysis
Change from baseline Sperm concentration at 1 month
时间窗: 1 month
Sperm concentration in semen analysis
Change from 1 month Sperm concentration at 6 months
时间窗: 6 months
Sperm concentration in semen analysis
Change from baseline Total Motility at 1 month
时间窗: 1 month
total motility of spermatozoa in semen analysis
Change from 1 month Total Motility at 6 months
时间窗: 6 months
total motility of spermatozoa in semen analysis
Change from baseline LH at 1 month
时间窗: 1 month
Plasmatic evaluation of LH
Change from 1 month LH at 6 months
时间窗: 6 months
Plasmatic evaluation of LH
Change from baseline Progressive motility at 1 month
时间窗: 1 month
Porgressive motility of spermatozoa in semen analysis
Change from 1 month Progressive motility at 6 months
时间窗: 6 months
Progressive motility of spermatozoa in semen analysis
Change from 1 month Vitality at 6 months
时间窗: 6 months
live spermatozoa
Change from 1 month Total testosterone at 6 months
时间窗: 6 months
plasmatic evaluation of total testosterone
Change from 1 month Prolactina at 6 months
时间窗: 6 months
plasmatic evaluation of prolactina
Change from baseline Sperm morphology at 1 month
时间窗: 1 month
normal forms of spermatozoa
Change from 1 month Sperm morphology at 6 months
时间窗: 6 months
normal forms of spermatozoa
Change from baseline FSH at 1 month
时间窗: 1 month
plasmatic evaluation of FSH
Change from 1 month FSH at 6 months
时间窗: 6 months
plasmatic evaluation of FSH
Change from baseline Total testosterone at 1 month
时间窗: 1 month
plasmatic evaluation of total testosterone
次要结局
未报告次要终点
研究者
Elisabetta Costantini
Clinical Professor
University Of Perugia