Fertility preservation in breast cancer patients: oocytes or embryos vitrification.

• Conditions: The aim of this trial is to offer a safe and efficient alternative protocol to preserve fertility by storing oocytes in breast cancer patients before chemotherapy. Letrozole, an inhibitor of aromatase, is administered during standard gonadotropins ovarian stimulation to maintain a low estradiol level during ovarian stimulation in patients with hormono-sensitive tumour.; MedDRA version: 18.1Level: LLTClassification code 10006190Term: Breast cancer invasive NOSSystem Organ Class: 100000004864; MedDRA version: 18.1Level: LLTClassification code 10016465Term: Fertility female decreasedSystem Organ Class: 100000004872; MedDRA version: 18.1Level: LLTClassification code 10016463Term: Fertility decreased femaleSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003412-31-BE
• Lead Sponsor: CUB - Hôpital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-03
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Woman 18-40 years old with breast cancer
-Referred for fertility preservation at least 13 days before starting chemotherapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

-Breast cancer TxNxM1
-Premature ovarian failure
-Poor ovarian function FSH>20mIU/ml
-Surgical contraindication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to evaluate the feasibility of gonadotropins ovarian stimulation associated with Letrozole before chemotherapy in breast cancer patients in order to preserve their fertility. <br>;Secondary Objective: The secondary objectives are to evaluate the efficiency (the success rate of the IVF, the feasibility of in vitro maturation of the immature oocytes collected) and the safety of the protocol for both patients and their offspring. ;Primary end point(s): The primary endpoint is to evaluate the feasability and the efficiency of the ovarian stimulation protocol (rate of mature oocytes collected and vitrify before chemotherapy). The maturation rate of oocytes collected will be compared to a prospective cohort of infertile patients treated with standard gonadotropins ovarian stimulation protocol without letrozole.<br>;Timepoint(s) of evaluation of this end point: Data collected at the time of oocytes collection