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

Breast Cancer Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Infertility

• NCT number: NCT02871167
• Study type: Interventional
• Source: Centre Oscar Lambret
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2016
• Completion date: December 2025