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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-01-31

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.

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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.

Conditions

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Hodgkin Lymphoma Hodgkin Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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case group

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.

Group Type EXPERIMENTAL

triptorelin

Intervention Type DRUG

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.

control group

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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triptorelin

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.

Intervention Type DRUG

Other Intervention Names

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triptorelin (Diphereline SR 3 mg, Ibsen)

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