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

18 Years
35 Years
Not Enrolling
Hodgkin Lymphoma, Hodgkin Disease

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Premature ovarian failure after chemotherapy

Outcome Description:

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

Outcome Time Frame:

6 months after the end of chemotherapy

Safety Issue:


Principal Investigator

Martin Huser, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masaryk University


Czech Republic: Grant Agency of the Ministry of Health

Study ID:

Masaryk University



Start Date:

January 2004

Completion Date:

January 2008

Related Keywords:

  • Hodgkin Lymphoma
  • Hodgkin Disease
  • Hodgkin lymphoma
  • Hodgkin disease
  • Hodgkin Disease
  • Lymphoma