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
- Conditions
- Idiophatic male infertilityMedDRA version: 9.1Level: SOCClassification code 10014698
- Registration Number
- EUCTR2010-020196-23-IT
- Lead Sponsor
- MERCK SERONO SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the effects of r-hFSH administration on sperm DNA fragmentation in idiopathic male infertility.;Secondary Objective: - to evaluate the effects of r-hFSH administration on seminal parameters: semen volume, spermconcentration, total sperm motility and normal morphology; to evaluate the effects of r-hFSH administration on hormonal parameters: FSH, LH, PRL, Testosterone, SHBG, Inhibin B and AMH levels; to evaluate the treatment safety.;Primary end point(s): The primary endpoint - the sperm DNA fragmentation change from baseline - is directly related to the main efficacy objective of the trial, i.e. the assessment of the r-hFSH treatment effects on sperm DNA fragmentation in idiopathic male infertility.
- Secondary Outcome Measures
Name Time Method