Efficacy and Tolerance of an Ovarian Stimulation Protocol Combining Follicle Stimulating Hormone (FSH) and Degarelix Acetate in Female Candidates for Fertility Preservation Before Chemotherapy for Breast Cancer

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The present investigation aims to evaluate the efficacy of an innovative protocol of controlled ovarian stimulation for breast cancer patients, who are candidates for fertility preservation.

Currently, vitrification of oocytes and/or embryos after controlled ovarian stimulation is the most established method for female fertility preservation. However, this stimulation induces an increase in serum estrogen levels, which is theoretically problematic in case of hormone-sensitive tumors such as breast cancer. The majority of oncology teams accept, in very specific situations (particularly when the tumor has been surgically removed), this ovarian stimulation, because the expected benefits of fertility preservation far outweigh the risks. However, everyone agrees that it would be more comfortable to be able to offer vitrification of oocytes and/or embryos using ovarian stimulation without increasing estrogen levels.

In this research, investigators will evaluate the efficacy of degarelix (Firmagon®), currently indicated for the treatment of prostate cancer, as an innovative ovarian stimulation procedure. Administered at the beginning of ovarian stimulation, they believe it should maintain serum estradiol levels at physiological values at the end of stimulation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Follicle Stimulating Hormone

Criteria

Inclusion Criteria:

• Patients with invasive ductal carcinoma breast cancer, whatever the hormonal receptor expression profile

• Age : 18 - 40 years

• Presence of 2 ovaries

• Antral follicular count between 12 and 30 on both ovaries and/or recent measurement of serum anti-Müllerian hormone between 1.5 and 4 ng / mL (between Day-25 and Day0)

• Indication of chemotherapy

• Indication of preservation of fertility according to an oocyte vitrification technique after controlled ovarian stimulation (COS)

• Patient in the early follicular phase of the cycle at the start of the controlled ovarian stimulation (COS) (absence of follicle> 10 mm in ultrasound and estradiolemia <50 pg / mL)

• Oncology team agreement for the controlled ovarian stimulation (COS)

• Social insured patient

• Patient who gave her consent to participate by signing the consent of the study

Exclusion Criteria:

• Patient in late follicular phase or luteal phase

• Known hypersensitivity to one of the constituents of Firmagon®