The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.
Medical Oncology: * Information and collection of consent, * Imaging staging, * Inclusion * Physical examination * Contraception advise given Reproductive medicine center: * Ovarian reserve assessment: serum anti-mullerian hormone (AMH) measurement and antral follicle count (AFC) by ultrasound. * Serology syphilis, hepatitis B and C, HIV (human immunodeficiency virus). In case of embryo cryopreservation, same serology determination for the men. * Infertility risk and fertility preservation techniques information. * In case of agreement, this technique will be done during the time-interval between surgery and chemotherapy * Fertility preservation (COH stimulation, triggering and oocyte retrieval) Adjuvant chemotherapy: * The chemotherapy regimen is 3 FEC (fluorouracil epirubicin cyclophosphamide) 100 followed by standard chemotherapy (according to local practice) +/- Trastuzumab. Adjuvant chemotherapy may only begin after the oocyte retrieval. * Usual adjuvant chemotherapy is not changed During chemotherapy: * Clinical exam before each cycle of chemotherapy * AMH, AFC at cycle 6 After chemotherapy: * Usual patient monitoring in expert center : physical examination at Month 3 (M3), M6 M9 M12 M18 and M24 and mammography at M9 then annual * AMH at Month 3 (M3), M6 M9 M12 M18 and M24 * AFC at Month 12 (M12) and M24
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
140
After information and consent, patients are addressed to a reproductive medicine center. The COH will be performed according to a standardized protocol between surgery and the start of adjuvant chemotherapy. Follicular growth will be achieved with an antagonist protocol and by using high dose recombinant FSH (r-FSH). The triggering of the final follicular and oocyte maturation will be obtained by a GnRH (Gonadotropin Releasing Hormone) agonist injection in order to minimize the risk of ovarian hyper-stimulation.
Egg or embryo freezing will be performed according to a standardized protocol: slow-freezing process for embryo; vitrification technique for oocytes. Cryopreserved oocytes and embryos will be stored in the biological bank of each reproductive medicine center (min. 10 years).
Hôpital Jean Verdier
Bondy, France
Quality of oocytes: total number of oocytes preserved
The distribution of the total number of oocytes preserved will be summarized by the mean (standard error) and median (range) and presented with a 95% confidence interval.
Time frame: after oocyte retrieval (35-36 hours after triptorelin injection)
Quality of embryos: total number of embryos preserved
Time frame: at 44-46 hours post intra-cell sperm injection
Type of oocytes
mature, immature, fractured
Time frame: after oocyte retrieval (35-36 hours after triptorelin injection)
Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale
Toxicities will be tabulated with frequencies and percentages by type of adverse events and by grade
Time frame: 24 months
Serum AMH measurement
Time frame: baseline, at the end of the first sequence of chemotherapy, at the last injection of treatment, at Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24
Antral Follicular Count (AFC) measurement
Time frame: baseline, at month 3, at month 12, at month 24
Number of Spontaneous or medically assisted pregnancy(ies)
To measure the degree of project completion of subsequent pregnancy(ies)
Time frame: up to 10 years after the end of the study or at 43 years old
Rate of patients wishing for re-utilization of their frozen gametes
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Centre Aliénor d'Aquitaine, Hôpital Pellegrin
Bordeaux, France
CHU de Caen
Caen, France
Centre François Baclesse
Caen, France
Hôpital Antoine Béclère
Clamart, France
Centre Georges François LECLERC
Dijon, France
CHU de Dijon
Dijon, France
CHU REUNION site SUD
La Réunion, France
Centre Oscar Lambret
Lille, France
CHRU Hôpital Jeanne de Flandres
Lille, France
...and 18 more locations
To assess the number of patients wishing for re-utilization of their frozen gametes
Time frame: up to 10 years after the end of the study or at 43 years old
Disease-free survival
defined as the interval between inclusion and the first occurrence of local, regional or distant relapse, estimated using the Kaplan-Meier method
Time frame: through study completion, an average of 5 years