Clinical trial · Interventional
Impact of the Inhibitors of Tyrosine Kinase on the Male Fertility
NCT01114087CI-TRIAL-00004628GLIFERTIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Patients presenting with chronic myeloid leukaemia or malignant GIST and receiving for the first time a treatment by imatinib, a tyrosin-kinase inhibitor, preceded or not by hydroxyurea therapy for less than one month.
- interventionNames
- Drug: Imatinib treatment
Primary outcomes (1)
- measure
- 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
Secondary outcomes (2)
- measure
- Analysis of the fragmentation of the spermatic DNA
- timeFrame
- At the inclusion and M6 visits
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.