NCT02871167进行中（未招募）不适用
Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 28
- 主要终点
- Quality of oocytes: total number of oocytes preserved
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically proven breast cancer
- •Aged 18 to 38 years old
- •Planned adjuvant chemotherapy
- •No prior chemotherapy
- •Affiliated to a public health insurance program
- •Informed consent signed by the patient
排除标准
- •Metastatic breast cancer
- •Planned neo-adjuvant chemotherapy
- •Hysterectomy
- •Exclusive adjuvant hormonotherapy
- •Positive serology for syphilis, hepatitis B or C, or VIH
- •Contraindication related to use of r-FSH
- •Pregnant or breastfeeding patients
研究组 & 干预措施
Oocyte/embryo cryopreservation
Experimental
- Controlled ovarian hyperstimulation (COH)
- Oocyte/embryo freezing
干预措施: Controlled ovarian hyperstimulation (COH) (Procedure)
Oocyte/embryo cryopreservation
Experimental
- Controlled ovarian hyperstimulation (COH)
- Oocyte/embryo freezing
干预措施: Oocyte/embryo freezing (Procedure)
结局指标
主要结局
Quality of oocytes: total number of oocytes preserved
时间窗: after oocyte retrieval (35-36 hours after triptorelin injection)
The distribution of the total number of oocytes preserved will be summarized by the mean (standard error) and median (range) and presented with a 95% confidence interval.
次要结局
- Rate of patients wishing for re-utilization of their frozen gametes(up to 10 years after the end of the study or at 43 years old)
- Type of oocytes(after oocyte retrieval (35-36 hours after triptorelin injection))
- Toxicity related to the controlled ovarian stimulation according to NCI CTCAE v4.0 scale(24 months)
- Antral Follicular Count (AFC) measurement(baseline, at month 3, at month 12, at month 24)
- Number of Spontaneous or medically assisted pregnancy(ies)(up to 10 years after the end of the study or at 43 years old)
- Disease-free survival(through study completion, an average of 5 years)
- Serum AMH measurement(baseline, at the end of the first sequence of chemotherapy, at the last injection of treatment, at Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24)
- Quality of embryos: total number of embryos preserved(at 44-46 hours post intra-cell sperm injection)
研究者
研究点 (28)
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