Clinical trial · Interventional
Co-treatment With GnRH Analogs on the Ovarian Reserve in Young Women Treated With Alkylating Agents for Cancer
Assessment of the Effect of a Co-treatment With GnRH Analogs on the Ovarian Reserve in Adolescents and Young Women Treated With Alkylating Agents for Cancer
NCT02856048CI-TRIAL-00042361PRESOVunknownPhase 2 / Phase 3ClinicalTrials.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)
The purpose of this study is to determine the efficacy of a temporary ovarian suppression obtained by administration of a gonadotropin releasing hormone agonist during alkylating agents containing chemotherapy on ovarian reserve assessed by Anti-Müllerian hormone (AMH) serum levels in adolescents and young women with cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Toxicity Due to Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Triptorelin (GnRHa) + Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Triptorelin (GnRHa) + Chemotherapy
- description
- Triptorelin LP 3 mg (DECAPEPTYL LP 3 mg, IPSEN) 3 mg every 28±3 days, intramuscular during chemotherapy
- interventionNames
- Drug: Triptorelin (GnRHa) + Chemotherapy
- type
- NO_INTERVENTION
- label
- Chemotherapy alone
- description
- Patient having a chemotherapy without drug injection for fertility preservation
Primary outcomes (1)
- measure
- Variation in AMH serum levels between both groups
- timeFrame
- at 24 months
- description
- Centralised hormonal dosages
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 12 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Female aged 12 to 25 years * Puberty Tanner 2 or more * Diagnosis of cancer: Sarcoma, Ewing, Osteosarcoma, Lymphoma * Chemotherapy protocol with alkylating agents at an intermediate ovarian toxicity risk (Cyclophosphamide 6 g/m2, Ifosfamide 50 g/m2, Procarbazine 4 g/m2, Lomustine 350 mg/m2 or Melphalan 140 mg/m2 or a combination of these drugs). * All patients with an osteosarcoma, Ewing sarcoma excepted pelvic localisation, Hodgkin lymphoma treatment group III (stages II B, III B and IV), B cell lymphoma group C, rhabdomyosarcoma treated with at least 8 Ifosfamide Vincristin Actinomycin (IVA) courses, synoviosarcoma group II T\>5 cm and group III, adult type sarcoma group I and II T\>5 cm and group III. * Before starting any chemotherapy * Covered by a medical insurance Exclusion Criteria: * Prepubertal * Pregnant * Planned brain or pelvic radiotherapy * Planned stem cell transplantation * Ovariectomy * Having already received chemotherapy with alkylating agents * Hypersensitivity to any component of GnRHa
References
Publications (0)
Data not yet available
No reference posted for this study.