Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation. Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Modifications of number of spermatozoa
研究概览
简要总结
Male Accessory Glands Inflammations (MAGI) include inflammatory diseases involving seminal vescicles and the prostate. Patients suffering from them present an impaired fertility because of seminal duct obstruction and alterations of the rheologic and functional parameters of semen, induced by direct microbiological action as well as inflammatory and oxidative damage. Inflammation in seminal plasma can be detected and measured by dosing of inflammatory molecules such as SuPAR and ST2. Treatment of MAGIs include specific antibiotic therapy in addition to use of anti-inflammatory nutraceutics. Deprox HP is a nutraceutic containing GraminexTM, a compound made of pollen extracts of rye, mais and timothy. To investigate its efficacy, we evalued seminal parameters, inflammatory and oxidative molecules in seminal plasma and clinical and ultrasonographic features of male accessory glands before and after 3 months of treatment in 20 patients taking Deprox HP and 20 patients undergoing treatment with palmitoilethanolammide, bromelin and horse chestnut extract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with a diagnosis of MAGI based on clinical and/or ultrasonographic criteria.
排除标准
- •History of cryptorchidism, orchitis, testicular torsion or trauma,
- •Hypogonadism,
- •Occupational chemical exposure,
- •Y chromosome microdeletions, karyotype abnormalities and Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutations,
- •ultrasound testicular volume <12 mL,
- •FSH >8 mUI/L,
- •fever or drug use within 3 months prior to the enrollment in this study
- •azoospermia.
研究组 & 干预措施
Group 1: Deprox HP
Patients with MAGI that will be given Deprox HP therapy
干预措施: Deprox_HP (Other)
Group 2: PEA+bromelin+horse chestnut extract
Patients with MAGI that will be given PEA+bromelin+horse chestnut extract
干预措施: Peacist (Other)
结局指标
主要结局
Modifications of number of spermatozoa
时间窗: 6 months
Modifications of the number of spermatozoa in Millions
Modification of sperm motility
时间窗: 6 months
Modification of sperm progressive motility in %
Modifications of number of typical forms
时间窗: 6 months
Modifications of number of typical forms in %
次要结局
- Modifications of seminal inflammatory parameters(6 months)
- Modifications of seminal oxidative parameters(6 months)