NCT02871167

Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation

Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Controlled ovarian hyperstimulation (COH)	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.
PROCEDURE	Oocyte/embryo freezing	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).

Timeline

• Start date: 2016-12-01
• Primary completion: 2024-06-05
• Completion: 2034-11-01
• First posted: 2016-08-18
• Last updated: 2026-03-18

Locations

28 sites across 1 country: France