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Trial · Interventional

CompletedNot applicableRegistry data

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

Short name OVARONKO

NCTNCT01764230 (opens ClinicalTrials.gov in a new tab)Other idMasaryk University
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
72 participants (actual)
Sponsor
Masaryk University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Czechia

Start
Jan 2004
Primary completion
Jul 2007
Completion
Jan 2008
First posted
9 Jan 2013 (estimated)
Last update posted
9 Jan 2013 (estimated)
Conditions
Hodgkin Lymphoma · Hodgkin Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420052006200720082009
  1. N/A

    OVARONKO

    NCT01764230

    Jan 2004 to Jan 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • triptorelinDrug

Arms2

  • Experimental

    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.

  • No intervention

    control group

    no intervention

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Premature ovarian failure after chemotherapy

    Time frame · 6 months after the end of chemotherapy

    Registry description

    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

    Registry description

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

Secondary outcomes(2)

  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

    Registry description

    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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2008

3 results

Prevention of ovarian function damage by a GnRH analogue during chemotherapy in Hodgkin lymphoma patients.

Huser et al. 2008Human reproduction (Oxford, England)cited by 32

PMID 18258763DOI 10.1093/humrep/den005PUB-18258763

Full text at the publisher3 results
Publisher pageSee results (3)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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