Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE) (fAMHOPE)

  • End date
    Jan 30, 2029
  • participants needed
  • sponsor
    Erasme University Hospital
Updated on 4 October 2022
breast cancer
stage iv breast cancer
breast carcinoma
adjuvant chemotherapy


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 refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.


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 patients with a Gonadotropin Releasing Hormone-GnRH agonist.

After retrieval, oocytes are denuded and matured oocytes are subjected to fertilization before embryo freezing or direct vitrification.

Primary objective is to evaluate the efficacy of performing a controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy in terms of mature oocytes collected.

Condition Breast Neoplasm Malignant Female
Treatment Letrozole, standard-stimulated cohort
Clinical Study IdentifierNCT04289805
SponsorErasme University Hospital
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer)
Prior diagnosis of other malignancies before breast cancer
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