NCT01268592终止不适用
Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- successful pregnancy
研究概览
简要总结
The purpose of this study is to preserve the fertility potential in females diagnosed with cancer by vitrifying (rapidly freezing) their oocytes (eggs) before undergoing treatment for their cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 42 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be 14-42 year old females with a cancer diagnosis.
- •Clearance letter from treating oncologist.
- •Approval by program oncologist or her designee.
- •Informed consent has to be signed after consultation with the program physician. Minors require consent of a parent or a legal guardian and assent from the participant.
- •Life expectancy (predicted by their malignancy) of 5 or more years.
- •Cancer diagnosis should have an expected cure rate of 50% or more, based upon clinico-pathologic features.
排除标准
- •Patients whose oncologist and the program oncologist concur that immediate oncologic care should be rendered, not allowing sufficient time for a course of gonadotropin therapy and egg retrieval.
- •FSH level >20 MIU/ml, indicating abnormal ovarian function.
- •Patients with stage IV cancers (*age appropriate women with stage IV advanced Hodgkin's Lymphoma will be considered, as there is a significant long term survival rate with this advanced disease).
- •Patients with incurable cancer diagnoses.
- •Patients who are unable or unwilling to sign the informed consent.
- •Women cannot have an embryo transfer beyond age 50.
研究组 & 干预措施
positive cancer diagnosis
Experimental
female patients diagnosed with cancer who wish to preserve their fertility by vitrifying their oocytes
干预措施: oocyte vitrification (Procedure)
结局指标
主要结局
successful pregnancy
时间窗: nine months after transfer of embryo(s)
the primary objective of this study is the establishment of a successful pregnancy, following a disease-free interval after treatment for her cancer; this interval will be patient-dependent and will undoubtedly vary between participants.
次要结局
- impact of stimulation on cancer recurrence(5 years after treatment)
研究者
研究点 (1)
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