Effects of Decrease in Cholesterol Levels Induced by a Statin on Sperm Quality
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Observations of all modifications on semen quality after 5 months of atorvastatin treatment
研究概览
简要总结
Recently, concerns about the effect of atorvastatin intake on men fertility have been raised. However, this statin has never been investigated regarding its influence on male fertility, notably sperm quality.
The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of cholesterol blood levels, induced by taking atorvastatin, on sperm quality of normocholesterolaemic and healthy men without confounding factors.
详细描述
The main objective is to estimate the safety of atorvastatin on fertility of normocholesterolaemic and healthy men (having normal blood lipid profile and normal sperm parameters) by analyzing its effects on sperm parameters: ejaculate volume, sperm count, total and progressive motility, percentage of typical forms.
The secondary objectives are to assess the changes in:
- hormonal profile: gonadotropins and testosterone plasma levels
- lipid composition of sperm and seminal fluid;
- spermatozoa capacitation markers
- accessory glands markers.
The efficacy is estimated by measuring the lipid lowering action of atorvastatin. It is expected a decrease by 20 and 40% of total cholesterol blood and LDL-cholesterol levels, respectively (total cholesterol <1.5 g / l and LDL-cholesterol <1g / l).
Considering this protocol as a pilot study to evaluate safety and efficacy, sample size estimation was fixed considering a Fleming design at one stage. These designs with one group and multi-stages (between 1 and 5) can be seen as filtering steps leading to the decision type go/no go. With a type I error a and statistical power (1-β) equals respectively 5% and 90%, n=17 subjects were necessary to reject the hypotheses of minimal (p=0.85) and maximal (p=0.95) acceptable non-toxicity. If 1 subject or more presented a toxicity, the treatment was considered no safe. To measure the evolution of total cholesterol and LDL-cholesterol levels concerning the efficacy, n=17 subjects were necessary to show a minimal paired difference (to be detected) of 0.5 with expected standard-deviation of difference = 0.5, correlation coefficient of 0.5, a= 5% (two-sided) for a power greater than 90% (1-β=97%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •between 18 and 65 years ;
- •with normal conventional semen parameters and negative semen culture according to WHO standards 1999 : volume ejaculate ≥ 2 ml, sperm count ≥ 20millions/ml, total motility ≥ 50% progressive motility ≥ 30%, typical forms ≥ 20%;
- •with normal blood lipid profile: total cholesterol < 2.50g/L, triglycerides < 1.70g/L, HDL-C > 0.35 g/L and LDL-C < 2.2 g/L;
- •without known pathology or ongoing treatment
排除标准
- •Subjects with medical or surgical history that may make them at risk during the study,
- •Subjects with cons-indications to taking atorvastatin
- •Subjects with an active liver disease or increased level of serum transaminases
- •Subjects with a history of allergy
- •Subjects whose lipid parameters do not match the inclusions criteria or receiving lipid-lowering therapy
- •Subject with abnormal semen analysis or cryptorchidism or a varicocele
- •Subjects who participated in another clinical trial or other experimentation or other tolerance study of a drug
研究组 & 干预措施
atovastatin
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Observations of all modifications on semen quality after 5 months of atorvastatin treatment
时间窗: at month 5
Observations of all modifications on semen quality after 5 months of atorvastatin treatment and after 3 months after its withdrawal
时间窗: at month 8
次要结局
- hormonal profile: gonadotropins and total testosterone plasma levels(at month 5)
- lipid composition of sperm and seminal fluid(at month 5)
- spermatozoa capacitation markers(at month 5)
- accessory glands markers(at month 5)