CompletedNot Applicable

Impact of the Inhibitors of Tyrosine Kinase on the Male Fertility

France2 participantsStarted 2008-10

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Average difference of the concentration of spermatozoa in the ejaculate measured before treatment and after 6 months of treatment.

Timeframe: At the inclusion and M6 visits

Trial details

NCT IDNCT01114087

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-05

View on ClinicalTrials.gov More Chronic Myeloid Leukemia trials