Chemotherapy as one of the basic modalities of oncology treatment often leaves permanent implications and among the most common is infertility as a result of irreversible gonadal damage. This project sets the primary target to verify the protective effect GnRH analogues administration to protect ovarian tissue during three different regimens of chemotherapy in patients with Hodgkin disease (HD) in reproductive age.
During the first two years of the project duration the curative anti-tumorous combined treatment in fertile patients with Hodgkin disease diagnosis will be carried out. Patients are to be divided into three groups according to the clinical stage of the disease and treated with the three types of the chemotherapeutic regimens comparable with toxicity. Patients will receive GnRH analogues during the chemotherapy for the gonadal protection by the mechanism of foliculogenesis inhibition in pre-pubertal stage. At the end of successful treatment according to stated criteria the ovarian function of every patient will be repeatedly evaluated in relation with toxicity of chemotherapy used. These ovarian function results will be compared with control group of patients without gonadal protection, which reproductive functions will be evaluated according the same method.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
72
Throughout the course of chemotherapy, patients were administered triptorelin (Diphereline SR 3 mg, Ibsen) in the form of i.m. injections, always once a month and simultaneously with the chemotherapy.
Brno University Hospital and Masaryk University School of Medicine
Brno, Czechia
Premature ovarian failure after chemotherapy
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
Time frame: 6 months after the end of chemotherapy
Premature ovarian failure after chemotherapy
Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.
Time frame: 12 months after the end of chemotherapy
Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
A - ABVD 4x Adriamycin, bleomycin, vinblastin and dacarbazin B Combination of ABVD and BEACOPP regimens 4x Adriamycin, bleomycin, vinblastin and dacarbazinþbleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine and prednisone C BEACOPP regimen 8x - Bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine and prednisone
Time frame: 6 months after the end of chemotherapy
Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
A - ABVD 4x Adriamycin, bleomycin, vinblastin and dacarbazin B Combination of ABVD and BEACOPP regimens 4x Adriamycin, bleomycin, vinblastin and dacarbazinþbleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine and prednisone C BEACOPP regimen 8x - Bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine and prednisone
Time frame: 12 month after chemotherapy
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