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

Last updated: January 29, 2025
Sponsor: Erasme University Hospital
Overall Status: Terminated

Phase

4

Condition

Neoplasms

Treatment

standard-stimulated cohort

Letrozole

Clinical Study ID

NCT04289805
SRB_201808_163
  • Ages 18-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 ≥ 6pmol (only applicable for patients who undergo controlled ovarian stimulation forembryo/oocyte cryopreservation).

Exclusion

Exclusion Criteria:

  • Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer);

  • Prior diagnosis of other malignancies before breast cancer.

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: standard-stimulated cohort
Phase: 4
Study Start date:
February 25, 2019
Estimated Completion Date:
January 15, 2025

Study 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 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.

Connect with a study center

  • CHIREC- Hospital Delta

    Brussel, 1160
    Belgium

    Site Not Available

  • CUB-Hôpital Erasme

    Brussel, 1070
    Belgium

    Site Not Available

  • CHC-Saint Vincent

    Liège, 4000
    Belgium

    Site Not Available

  • CHRU Lille

    Lille, 59037
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, 59000
    France

    Site Not Available

  • Ospedale San Martino

    Genova, 16132
    Italy

    Site Not Available

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