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

  • STATUS
    Recruiting
  • End date
    Jan 25, 2027
  • participants needed
    565
  • sponsor
    Erasme University Hospital
Updated on 23 January 2021
cancer
breast cancer
stage iv breast cancer
breast carcinoma
letrozole
adjuvant chemotherapy

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 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.

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 patients with a 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.

Details
Condition Breast Neoplasm Malignant Female
Treatment Letrozole, standard-stimulated cohort
Clinical Study IdentifierNCT04289805
SponsorErasme University Hospital
Last Modified on23 January 2021

Eligibility

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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