Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality: Post-hoc Analyses From a Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 主要终点
- Evaluation of sperm concentration (millions/ml) on spermogram of infertile men
研究概览
简要总结
Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation.
This randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post-hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind placebo controlled trial
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
- •men with oligo- and/or astheno- and/or terato-zoospermia
- •with or without varicocele
- •men aged between 18 and 50 years
- •men from couples with history of difficulty conceiving for more than 12 months
排除标准
- •subjects with known hypersensitivity to any of the treatment compound
- •history of undescended testes or cancer
- •endocrine disorders
- •history of post-pubertal mumps
- •genitourinary surgery
- •obstructive azoospermia or obstructive pathology of the urogenital system
- •autoimmune disease
- •cystic fibrosis
- •history of taking any therapy affecting fertility within last 3 months
- •excessive consumption of alcohol or regular use of illicit or "recreational" drugs
- •positive serology for HIV
- •subjects following any special diet
- •any condition which in the opinion of the investigator might put the subject at risk by participation in this study and subjects involved in any other clinical trials
结局指标
主要结局
Evaluation of sperm concentration (millions/ml) on spermogram of infertile men
时间窗: 6 months
Efficacy of the therapy on sperm concentration (millions/ml) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.
Evaluation of sperm motility (%) on spermogram of infertile men
时间窗: 6 months
Efficacy of the therapy on sperm motility (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.
Evaluation of sperm normal morphology (%) on spermogram of infertile men
时间窗: 6 months
Efficacy of the therapy on sperm normal morphology (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.
次要结局
- Evaluation of pregnancy rate (number)(6 months)
研究者
Ettore De Berardinis
Principal Investigator
University of Roma La Sapienza