Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT02871167
Brief 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
Study:
NCT02871167
Study Brief:
Protocol Section:
NCT02871167