Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Number of subjects who elect to have ovarian tissue cryopreservation in one year.
研究概览
简要总结
The purpose of this research is to obtain ovarian tissue from female participants who will receive therapy which is expected to result in a loss or impairment of ovarian function and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of initiating a pregnancy in the future.
Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue will be used for the participant's future use. There have been 86 pregnancies as a result of frozen ovarian tissue that has been re-implanted back into the pelvis and hormonal function has been restored in individuals for up to 7 years.
By doing this study, the investigators hope to learn of how to successfully freeze and thaw ovarian tissue in a manner that permits subsequent use by patients at some point in the future. Participation may also advance our knowledge of how to successfully mature follicles and oocytes (eggs) that are contained in these tissues which may help others in the future.
详细描述
The research procedures will be conducted at the University of Kentucky (UK) Medical Center.
Participants in the study will provide ovarian tissue cryopreservation for their own personal use.
The duration of the study will be until the participant reaches age 41 years. Participants will be broken out into four categories:
Participants will have surgical removal of their ovarian tissue using the methods determined by their surgeon based on their medical/surgical diagnosis or treatment. Participants in one of the following categories will participant in the study:
- Participants have elected to have one or both ovaries removed for the treatment or prevention of disease.
- Participants 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 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 but who cannot or will not provide tissue to the research pool (except that ovarian cortex for 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 candidates for or choose not to use more mature fertility preservation technologies.
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
- 12 Years 至 41 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergo standard of care 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.
- •May have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis are eligible if they have not received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
- •Participant undergoing elective removal of an ovary for fertility preservation only must have two ovaries.
- •Participant who already has stored cryopreserved ovarian tissue in a frozen state prior to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible for enrollment with informed consent.
- •Is not a candidate for or chooses not to utilize embryo or oocyte banking.
排除标准
- •Psychological, psychiatric or other conditions which prevent giving fully informed consent.
- •Underlying medical condition which significantly increases risk of complications from anesthesia and surgery.
- •Participants with a large cancerous mass in the ovary that is being removed; cryopreservation will not be performed on portions of the ovary.
- •Blood testing indicates that the participant does not have enough eggs remaining in her ovary.
结局指标
主要结局
Number of subjects who elect to have ovarian tissue cryopreservation in one year.
时间窗: 1 year from IRB protocol approval and study open date
The investigator will describe the number of subjects who elect ovarian tissue cryopreservation (OTC) over a 1 year period of time to determine feasibility of OTC in oncology subjects receiving chemotherapy and radiation.
次要结局
- Number of subjects who elect to have ovarian tissue cryopreservation over a 5 year prior period of time.(5 years from IRB protocol approval and study open date)
研究者
Vlad Radulescu
Professor
University of Kentucky