Idiophatic male infertility MedDRA version: 9.1 Level: SOC Classification code 10014698
Conditions
Interventions
Trade Name: GONAL F 150
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Follitropin alfa
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1
Sponsors
MERCK SERONO SPA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed