Clinical trial NCT01764230: Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients
Official title: Prevention of Ovarian Function Damage by a GnRH Analogue During Chemotherapy in Hodgkin Lymphoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin Lymphoma
Hodgkin Disease
Keywords: Hodgkin lymphoma
Hodgkin disease
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Czech Republic
First posted: 2013-01-09
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Premature ovarian failure after chemotherapy
timeFrame: 6 months after the end of chemotherapy
measure: Premature ovarian failure after chemotherapy
timeFrame: 12 months after the end of chemotherapy
Secondary outcomes:
measure: Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
timeFrame: 6 months after the end of chemotherapy
measure: Rate of premature ovarian failure according to the degree of toxicity of the chemotherapeutic regimen
timeFrame: 12 month after chemotherapy
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Brno University Hospital and Masaryk University School of Medicine
Study officials:
affiliation: Masaryk University
name: Martin Huser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huser M, Crha I, Ventruba P, Hudecek R, Zakova J, Smardova L, Kral Z, Jarkovsky J. Prevention of ovarian function damage by a GnRH analogue during chemotherapy in Hodgkin lymphoma patients. Hum Reprod. 2008 Apr;23(4):863-8. doi: 10.1093/humrep/den005. Epub 2008 Feb 7.