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

Masaryk University

Status: Completed

Conditions: Hodgkin Lymphoma; Hodgkin Disease

Treatments: Drug: triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT01764230

Masaryk University

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

case group

Experimental group

Description:

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.

Treatment:

Drug: triptorelin

control group

No Intervention group

Description:

no intervention