Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Breast Neoplasm Malignant Female
Type
Interventional
Phase
Phase 4
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 3 groups: 113 patients in the standard-stimulated cohort, 113 patients in the letrozole-stimulated cohort, 339 patients in the non-stimulated cohort. Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 40 years
Gender
Only males

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...

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.

Tracking Information

NCT #
NCT04289805
Collaborators
University Hospital, Lille
Investigators
Study Director: Isabelle Demeestere, MD, PhD CUB-Hôpital Erasme Study Chair: Matteo Lambertini, MD, PhD ULB Study Chair: Christine Decanter, MD CHRU Lille