Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients

Conditions
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Hodgkin Lymphoma, Hodgkin Disease

Intervention / Treatment
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* Drug: triptorelin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of Hodgkin lymphoma FSH and LH levels in peripheral blood below 15 IU/l fertile age from 18 to 35 years female presence of both ovaries Exclusion Criteria: ovarian tumours or cysts over 40 mm in diameter

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: case group<br>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. | Drug: triptorelin<br>* 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.<br>* Other names: triptorelin (Diphereline SR 3 mg, Ibsen);|
| No Intervention: control group<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature ovarian failure after chemotherapy | Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood. | 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. | 12 months after the end of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 month after chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin lymphoma, Hodgkin disease