Clinical trial · Interventional
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
Efficacy and Tolerance of an Ovarian Stimulation Protocol Combining FSH and Degarelix Acetate in Female Candidates for Fertility Preservation Before Chemotherapy for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Ductal Breast Carcinoma | Invasive Breast Carcinoma of No Special Type | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix injection(s) | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- one arm
- description
- one arm
- interventionNames
- Drug: Degarelix injection(s)
Primary outcomes (1)
- measure
- Number of follicles 16 to 20 mm in diameter obtained with estradiolemia <500 pg /mL
- timeFrame
- Day of ovulation trigger
- description
- Success of the procedure if at least 4 follicles 16 to 20 mm in diameter are obtained on the day of ovulation trigger (36 hours before oocyte collection) with estradiolemia \<500 pg / mL
Secondary outcomes (6)
- measure
- Serum estradiol levels
- timeFrame
- Day of ovulation trigger
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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®
References
Publications (0)
Data not yet available