The patient with diagnosis: Hodgkin disease and leukaemia. Patients starting at adolescence (B3 - B4 for breast development accordig Tanner criteria) till 34 years be included.
Conditions
Interventions
Trade Name: DIPHERELINE S.R. 3mg
Product Name: Diphereline S.R. 3 MG INJ
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
Endocrine Society of Czech Republic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female subjects with normal gonadal function and with first manifestation of malign disease (Hodgkin lymphoma and leukaemia), who will undergo cytostatic treatment with high risk of gonadal damage and who are interested in fertility. Female subjects in fertile period (starting with perimenarcheal period B3-B4 acording Tanner criteria) till 34 years of age With one of following malign diseases: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin’s lymphoma Not yet treated for malign disease, with normal ovarian functions Signed informed consent No hormonal replacement 3 months before initiation of the study No hormonal contraception before first injection of study medication In the case of oocyte harvesting and cryopreservation of oocytes after hormonal stimulation (for the future IVF) last menstrual bleeding must folow Pregnancy test must be negative Are the trial subjects under 18? yes 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
Exclusion criteria: Subjects undergoing transplantation of hemopoetic blood cells and / or whole body irradiation Subjects without uterus Subjects with contraindication of gravidity Subjects without fertility interest Subjects with abormal gonadal function 6 months before the onset of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: AIM OF THE PROJECT Achievement and maintenance of transitory and targeted protective suppression of reproduction axis during antitumour treatment Observation of gonadal function after treatment termination Assessment of reproduction functions and of fertility after treatment ;Secondary Objective: Assessment of protective influence of pharmacological gonadal protection on occurrence of severe metrorrhagias during antitumour treatment;Primary end point(s): Detection of gonadal damage | — |
Countries
Czech Republic
Outcome results
None listed