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

What Was Tested

The trial (not phased) is built around Triptorelin.

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.

It had two arms (groups): case group (experimental) and control group (no intervention).

No intervention.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 72 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of Hodgkin lymphoma. Fertile age from 18 to 35 years. Presence of both ovaries.

The full record lists 5 inclusion and 1 exclusion criteria; among the exclusions: ovarian tumours or cysts over 40 mm in diameter.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2004-01 with completion listed for 2007-07.

It ran at 1 site in Czechia.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Premature ovarian failure after chemotherapy (time frame: 6 months after the end of chemotherapy). Premature ovarian failure after chemotherapy (time frame: 12 months after the end of chemotherapy).

It also tracked 2 secondary outcomes, for example Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen and Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Triptorelin in 72 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.