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

Phase 4TerminatedNCT04289805

Erasme University Hospital96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Breast Neoplasm Malignant Female

Interventions

LetrozoleDRUG

Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol. "Standard Protocol": letrozole is orally administered (5mg/d) from cycle day 2-3 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering. "Random start" protocol: letrozole is administered throughout the stimulation together with gonadotropins. GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm. Oocytes are collected 36h after ovulation triggering with GnRH agonist.

standard-stimulated cohortOTHER

Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol. "Standard Protocol": Gonadotrophins started from cycle day 2-3 throughout the ovarian stimulation until ovulation triggering. "Random start" protocol: Gonadotrophins started at any time of the cycle and throughout the stimulation. GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm. Oocytes are collected 36h after ovulation triggering with GnRH agonist.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (6)

CUB-Hôpital Erasme

Brussels, Belgium

CHIREC- Hospital Delta

Brussels, Belgium

CHC-Saint Vincent

Liège, Belgium

Centre Oscar Lambret

Lille, France

CHRU Lille

Outcomes

Primary Outcomes

Efficacy of the ovarian stimulation and oocyte collection procedure: Number of mature oocytes collected

Number of mature oocytes collected

Time frame: an average of 2 weeks after inclusion

Secondary Outcomes

Number of patient with adverse events due to COS: OHSS

Adverse events reporting during COS (Ovarian Hyperstimulation syndrome-OHSS)

Time frame: Through treatment procedure, an average of 2 weeks after inclusion

Characteristics of Ovarian stimulation: total gonadotropin doses

Total gonadotropin doses (International Unit- IU)

Time frame: An average of 2 weeks after inclusion

Characteristics of Ovarian stimulation: duration of the COS

duration of the COS (days)

Time frame: An average of 2 weeks after inclusion

Characteristics of Ovarian stimulation: type of stimulation

type of stimulation (standard or random-start).

Time frame: An average of 2 weeks after inclusion

Efficacy of the ovarian stimulation and oocyte collection: Maturation rate

Maturation rate (number of total oocyte collected/number of mature oocytes)

Time frame: An average of 2 weeks after inclusion

Outcomes of assisted reproductive technology procedures

Number of pregnancies and outcomes (premature delivery, miscarriage, abortion, delivery healthy babies, congenital malformation).

Time frame: Through study completion, 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.