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NCT Number: NCT01764230

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

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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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brno University Hospital and Masaryk University School of Medicine

Brno, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triptorelin

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.

Other names: triptorelin (Diphereline SR 3 mg, Ibsen)

Primary outcomes

  1. Premature ovarian failure after chemotherapy

    Time frame: 6 months after the end of chemotherapy

    Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.

  2. Premature ovarian failure after chemotherapy

    Time frame: 12 months after the end of chemotherapy

    Premature ovarian failure defined as levels of FSH over 15 IU/l in peripheral blood.

Secondary outcomes

  1. Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen

    Time frame: 6 months after the end of chemotherapy

    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

  2. Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen

    Time frame: 12 month after chemotherapy

    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

Sponsors and collaborators

Lead sponsor

Masaryk University

Other

Collaborators

  • Ministry of Health, Czech Republic

Registry information

Acronym: OVARONKO

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Jan 9, 2013
Registry last updated
Jan 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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