NCT01764230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

3.5 years

First QC Date

December 30, 2012

Last Update Submit

January 7, 2013

Conditions

Hodgkin LymphomaHodgkin Disease

Keywords

Hodgkin lymphomaHodgkin disease

Outcome Measures

Primary Outcomes (2)

  • Premature ovarian failure after chemotherapy

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

    6 months after the end of chemotherapy

  • Premature ovarian failure after chemotherapy

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

    12 months after the end of chemotherapy

Secondary Outcomes (2)

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

    6 months after the end of chemotherapy

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

    12 month after chemotherapy

Study Arms (2)

case group

EXPERIMENTAL

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.

Drug: triptorelin

control group

NO INTERVENTION

no intervention

Interventions

triptorelinDRUG

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.

Also known as: triptorelin (Diphereline SR 3 mg, Ibsen)
case group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • ovarian tumours or cysts over 40 mm in diameter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital and Masaryk University School of Medicine

Brno, 62500, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 18258763RESULT

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Martin Huser, MD, PhD

    Masaryk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD.

Study Record Dates

First Submitted

December 30, 2012

First Posted

January 9, 2013

Study Start

January 1, 2004

Primary Completion

July 1, 2007

Study Completion

January 1, 2008

Last Updated

January 9, 2013

Record last verified: 2013-01

Locations

CZ(1)