Chronic Myeloid Leukemia Clinical Trial
— GLIFERTIOfficial title:
Impact of the Inhibitors of Tyrosine Kinase on the Male Fertility
Verified date | January 2011 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
Evaluate the possible deleterious effects of tyrosine kinase inhibitors on sperm concentration, after 6 months of therapy, which corresponds to 2 cycles of spermatogenesis and on the sperm nuclear integrity. The main comparison criterion will be the mean difference in sperm concentration before and after the 6 month treatment.
Status | Completed |
Enrollment | 2 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Men from 18 to 60 years old - Patients recently diagnosed CML or GIST - Patients for whom a treatment by an inhibitor of tyrosine kinase in monotherapy is prescribed - Patients having signed the informed consent - Patients with social security Exclusion Criteria: - Patients already subjected to a treatment potentially sterilizing - Patients under supervision or guardianship |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Department of Biology of reproduction (TENON Hospital-APHP) | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average difference of the concentration of spermatozoa in the ejaculate measured before treatment and after 6 months of treatment. | At the inclusion and M6 visits | No | |
Secondary | Analysis of the fragmentation of the spermatic DNA | At the inclusion and M6 visits | No | |
Secondary | Plasmatic concentration of the inhibitors of tyrosine kinase | At the inclusion and M6 visits | No |
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