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Clinical Trials/EUCTR2010-020196-23-IT
EUCTR2010-020196-23-IT
Active, not recruiting
Phase 1

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

MERCK SERONO SPA0 sites0 target enrollmentFebruary 8, 2011
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ConditionsIdiophatic male infertilityMedDRA version: 9.1Level: SOCClassification code 10014698
DrugsGONAL F 150

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Idiophatic male infertility
Sponsor
MERCK SERONO SPA
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 8, 2011
End Date
February 28, 2013
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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