A Prospective Open Randomized Trial on the Efficacy of Gonadotropin-releasing Hormone Agonist Depot-Triptorelin- to Prevent Chemotherapy Induced Premature Ovarian Failure in Lymphoma Patients.
18 Years
45 Years
Female
Ovarian Function Restoration After Chemotherapy for Lymphoma
Trial Information
A Prospective Open Randomized Trial on the Efficacy of Gonadotropin-releasing Hormone Agonist Depot-Triptorelin- to Prevent Chemotherapy Induced Premature Ovarian Failure in Lymphoma Patients.
Inclusion Criteria:
- Women between 18 and 45 years old with lymphoma.
- Menarche >2year
- Subject treated by chemotherapy-induced ovarian failure including alkylant agents
(except less than 8 ABVD)
- Presence of both ovaries (ovarian biopsy or hemiovariectomy for cryopreservation
before treatment is accepted).
- Ability to give written informed consent
Exclusion Criteria:
- Hormonal-sensible malignancy
- Chemotherapy or radiotherapy before the inclusion in the study
- Pelvic irradiation including the ovaries or TBI
- Pregnancy
- Patient weight above 110 kg
- Anamnesis of thrombo-embolic processes
- Severe hepatic or renal insufficiency
- Systolic blood pressure >15mmHg or diastolic blood pressure > 90mmHg
- Contraindication of IM injection
- Relevant ovarian abnormalities (Functional follicular cyst are tolerated)
- Anamnesis of premature ovarian failure or irregular cycle (repeated amenorrhoea >2
months)
- Dubin-Johnson and Rotor Syndrome
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Premature ovarian failure rate
Outcome Description:
Primary endpoint is to evaluate the short and long-term efficacy of triptorelin depot plus progestin versus progestin alone to prevent POF induced by chemotherapy treatment. The ovarian function (FSH, E2, Progesterone, and AMH, presence of spontaneous menstrual cycle and pregnancies) will be evaluated every 3 months during the first 6 months after the end of chemotherapy, every 6 months during the next 18 months and once a year during an additional 5 years. All hormonal treatment has to be interrupted 10 days before the blood test.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Yvon Englert, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Erasme Hospital
Authority:
Belgium: Ethics Committee
Study ID:
ErasmeUH
NCT ID:
NCT01160315
Start Date:
July 2002
Completion Date:
June 2017
Related Keywords:
- Ovarian Function Restoration After Chemotherapy for Lymphoma
- ovarian failure, chemotherapy, lymphoma, GnRH agonist
- Lymphoma
- Menopause, Premature
- Primary Ovarian Insufficiency
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