A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 96
- 试验地点
- 6
- 主要终点
- Efficacy of the ovarian stimulation and oocyte collection procedure: Number of mature oocytes collected
研究概览
简要总结
This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.
详细描述
Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all patients with a Gonadotropin Releasing Hormone-GnRH agonist.
After retrieval, oocytes are denuded and matured oocytes are subjected to fertilization before embryo freezing or direct vitrification.
Primary objective is to evaluate the efficacy of performing a controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy in terms of mature oocytes collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of invasive non-metastatic breast cancer (i.e. stage I to III);
- •Breast cancer diagnosis ≥18 and ≤ 40 years;
- •No prior history of gonadotoxic treatments;
- •Fertility preservation counseling for fertility preservation;
- •Written inform consent;
- •FSH < 20 UI/L and/or antra-follicular count ≥ 6 (follicles of 2-9 mm) and/or AMH ≥ 6 pmol (only applicable for patients who undergo controlled ovarian stimulation for embryo/oocyte cryopreservation).
排除标准
- •Newly diagnosed stage IV breast cancer (i.e. de novo metastatic breast cancer);
- •Prior diagnosis of other malignancies before breast cancer.
研究组 & 干预措施
standard-stimulated cohort
this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the French participating centres.
干预措施: standard-stimulated cohort (Other)
letrozole-stimulated cohort
this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the Belgian participating centres.
干预措施: Letrozole (Drug)
结局指标
主要结局
Efficacy of the ovarian stimulation and oocyte collection procedure: Number of mature oocytes collected
时间窗: an average of 2 weeks after inclusion
Number of mature oocytes collected
次要结局
- Efficacy of the ovarian stimulation and oocyte collection: Maturation rate(An average of 2 weeks after inclusion)
- Anticancer therapies effect on ovarian function: FSH(Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months)
- Number of patient with adverse events due to COS: OHSS(Through treatment procedure, an average of 2 weeks after inclusion)
- Characteristics of Ovarian stimulation: duration of the COS(An average of 2 weeks after inclusion)
- Characteristics of Ovarian stimulation: type of stimulation(An average of 2 weeks after inclusion)
- Circulating breast cancer cells level after stimulation(average of 2weeks after inclusion)
- Number of patient with adverse events due to egg collection(An average of 2 weeks after inclusion)
- Anticancer therapies effect on ovarian function: AMH(Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months)
- Oncological outcomes 1(5 years)
- Efficacy of the in vitro fertilization procedure: Fertilization rate(Through study completion, 5 years)
- Characteristics of Ovarian stimulation: total gonadotropin doses(An average of 2 weeks after inclusion)
- Anticancer therapies effect on ovarian function(An average 18 months, 30 months, 60 months after inclusion)
- Oncological outcomes 2(5 years)
- Outcomes of assisted reproductive technology procedures(Through study completion, 5 years)
- Anticancer therapies effect on ovarian function: progesterone(Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months)
- Anticancer therapies effect on ovarian function: E2(Inclusion, an average of 2 weeks, 6 months, 18 months, 30 months, 60 months)
- Oncological outcomes 3(5 years)
- Circulating breast cancer cells level before stimulation(Inclusion)