Status:
TERMINATED
Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
Lead Sponsor:
Erasme University Hospital
Collaborating Sponsors:
University Hospital, Lille
Conditions:
Breast Neoplasm Malignant Female
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refinin...
Detailed Description
Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all ...
Eligibility Criteria
Inclusion
- Diagnosis of invasive non-metastatic breast cancer (i.e. stage I to III);
- Breast cancer diagnosis ≥18 and ≤ 40 years;
- No prior history of gonadotoxic treatments;
- Fertility preservation counseling for fertility preservation;
- Written inform consent;
- FSH \< 20 UI/L and/or antra-follicular count ≥ 6 (follicles of 2-9 mm) and/or AMH ≥ 6 pmol (only applicable for patients who undergo controlled ovarian stimulation for embryo/oocyte cryopreservation).
Exclusion
- Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer);
- Prior diagnosis of other malignancies before breast cancer.
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04289805
Start Date
February 25 2019
End Date
January 15 2025
Last Update
January 31 2025
Active Locations (6)
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1
CUB-Hôpital Erasme
Brussels, Belgium, 1070
2
CHIREC- Hospital Delta
Brussels, Belgium, 1160
3
CHC-Saint Vincent
Liège, Belgium, 4000
4
Centre Oscar Lambret
Lille, France, 59000