Status:
COMPLETED
Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure
Lead Sponsor:
Erasme University Hospital
Collaborating Sponsors:
Fonds National de la Recherche Scientifique
Ipsen
Conditions:
Fertility Preservation
Alkylating Agents
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to treat neoplastic and benign diseases. These drugs are definitely associated with premature ovarian failure...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01160315
Start Date
July 1 2002
End Date
October 1 2015
Last Update
October 30 2015
Active Locations (15)
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1
Algemeen Ziekenhuis Stuivenberg
Antwerp, Belgium, 2060
2
AZ St Jan
Brugges, Belgium, 8000
3
Bordet
Brussels, Belgium, 1000
4
Erasme Hospital
Brussels, Belgium, 1070