EUCTR2010-020196-23-IT进行中（未招募）1 期
A phase II, multicentre, open label, prospective, interventional study to evaluate the sperm DNA fragmentation in idiopathic male infertility before and after treatment with Gonal-f PEN 900 IU. - ND
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Male subjects with idiopathic infertility aged between 18-45 years inclusive; 2. Sperm concentration > 10 million/ejaculate; 3. Total sperm motility >5 % and 25%; 4. Percentage of Atypical Forms > 70 %; 5. FSH value at baseline >1 and 7 IU/l; 6.Written informed consent given before any trial-related activities.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects at high risk of sperm DNA fragmentation as exposed to factors that are known to be the cause of sperm DNA fragmentation and infertility: exposure to environmental or industrial toxins, oxidative stress and smoke; 2. Subjects with Hypogonadotropic Hypogonadism; 3. Smoker subjects: number of cigarettes 20/day; 4. Subjects ex-heavy smokers ( 41 cigarettes/day, with discontinuation within the prior 6months); 5. Documented presence of urogenital tract infections (chlamydia, ureaplasma, mycoplasma); 6. Any clinically important systemic disease (e.g. insulin-dependent diabetes mellitus, epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular disease, serious corticoid-dependent asthma) which constitutes a contraindication to gonadotropin use; 7. Subjects with diagnosed or suspected malignant androgen dependent tumours; 8. Subjects with genetic disorders; 9. Subjects who have undergone surgery or medical treatment in the three months before the study inclusion; 10. Any medical condition which, according to the investigator?s judgment, may affect the absorption, distribution, metabolism or excretion of the drug; 11. Any other medication or treatment that might modify or interfere with sperm DNA fragmentation (antioxidants, vitamins, anti inflammatory, antibiotics, antineoplastics); 12. Subject with documented presence of Varicocele (III degree or higher) and Hydrocele; 13. Subjects with a history of injury to testes; 14. Participation in another clinical trial within the past 30 days; 15. Legal incapacity or limited legal capacity; 16. Known hypersensitivity to the trial treatment or excipients.
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