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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2025-01-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Neoplasm Malignant Female

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

3 groups:

* 113 patients in the standard-stimulated cohort,
* 113 patients in the letrozole-stimulated cohort,
* 339 patients in the non-stimulated cohort.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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standard-stimulated cohort

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the French participating centres.

Group Type ACTIVE_COMPARATOR

standard-stimulated cohort

Intervention Type OTHER

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.

letrozole-stimulated cohort

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the Belgian participating centres.

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

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.

non-stimulated cohort

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and who have access to the Fertility Clinics in all the participating centres but are not willing to preserve their fertility by undergoing oocyte/embryo cryopreservation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Letrozole

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.

Intervention Type DRUG

standard-stimulated cohort

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.

Intervention Type OTHER

Other Intervention Names

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Controlled Ovarian Stimulation (COS) COS

Eligibility Criteria

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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).