Fertility Preservation With Ovarian Tissue Freezing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Cryopreservation of ovarian tissu by vitrification
研究概览
简要总结
The purpose of this study is to obtain ovarian tissue from female patients undergoing gonadotoxic treatments or gonadal ablating surgery, and that in consequence may see their future fertility impaired. Participants will be offered to preserve (freeze) and use ovarian tissue for the purpose of conceiving in the future.
Although, 86 live births have been reported with ovarian tissue cryo-preservation and grafting, the procedure is still considered experimental.
This research, will help us to learn and validate how to perform ovarian tissue cryo-preservation and thawing in the fertility preservation context.
详细描述
his Study will conducted at the Centre Hospitalier Universitaire Ste-Justine Collected ovarian tissue will only be for the patients own use.
Subjects will undergo surgical removal of their ovarian tissue, and the following categories will be invited to participate:
- Patients have elected to have one or both ovaries removed for the treatment or prevention of disease.
- Patients who have elected to have surgery to remove all or part of one or both ovaries for medical reasons where cryopreservation of the remaining limited portions of normal ovarian cortex is the only option for fertility preservation at the time (except that ovarian cortex from the ovary that contains the mass will not be cryopreserved).
- Participants who have elected to have one or part of one ovary removed, solely for the purpose of fertility preservation because they are not candies to use standard fertility preservation technologies.
If the subject chooses to participate and consent, she will be assessed to determine her eligibility The subject will also have a serum AMH drawn for the evaluation of the ovarian reserve, and also infectious disease testing will also be performed per Health Canada guidelines.
The oophorectomie will be performed laparoscopically under general anesthesia. In patients' in whom it is medically unsafe or not feasible to complete the surgery laparoscopically, the patient and/or legal gardian may opt to proceed with a mini-laparotomy or laparotomy approach or may opt to stop the procedure and withdraw from the study at that time. This decision will be discussed with the patient and legal gardian during the consenting process and documented prior to the surgery. The procedural risk and treatment delays will be discussed with the primary treatment team in order to provide a better evaluation of the patients wellbeing. This procedure is performed for fertility preservation purposes only, but can potentially be coordinated with another procedure such as placement of a central line for future chemotherapy. In the event the subject is undergoing a surgical intervention for other indications, the oophorectomies could be coordinated at the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, > 2 month and < 18 years of age
- •Undergo surgery, chemotherapy, drug treatment, and/or radiation for the treatment or prevention of a medical condition or malignancy expected to result in permanent and complete loss of subsequent ovarian function.
- •Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
- •Subject may have newly diagnosed or recurrent disease.
- •Subject who already has stored cryopreserved ovarian tissue in a frozen state prior to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible for enrolment with informed consent.
- •Subject not eligible to standard fertility preservation
- •The subject and/or the subject's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies.
排除标准
- •Women with psychological, psychiatric or other conditions which prevent giving fully informed consent.
- •Women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
- •Women to whom the research intervention may decrease the survival or the treatment response to the underlying disease.
- •AMH (Anti Müllerian Hormone) <0.016 ng/dl
- •Women whose surgery is preformed outside the CHU Ste-Justine
- •Patients eligible to a standard fertility preservation procedure.
结局指标
主要结局
Cryopreservation of ovarian tissu by vitrification
时间窗: 5 years
Measure the fertility rate of cryopreservation and grafting by ovarian tissue vitrification.
次要结局
未报告次要终点
研究者
Julio Saumet-Chilito
Physician, Director of fertility preservation department
St. Justine's Hospital