Gonadal Tissue Cryopreservation for Fertility Preservation in Children With a Disorder of Sex Development
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of Sex Development
研究概览
简要总结
The purpose of this study is to offer gonadal tissue freezing and storage to children who are diagnosed with a disorder of sex development (DSD), who are at increased risk of infertility and certain malignancies (cancer). This study involves the storage of gonadal tissue that is being removed for medical reasons (e.g. prevention of cancer development). It includes the processing and freezing of this gonadal tissue, hopefully for potential future use. The tissue will then be stored long-term until the child wishes to try to use the tissue.
详细描述
DSD are conditions in which there is incongruence in an individual's chromosomal, gonadal, or phenotypic sex (refers to sex as determined by an individual's internal or external genitalia and expression of secondary sex characteristics).Different DSD diagnoses have varying degrees of risk for future malignancy. The treating doctor has or will discuss with the participant the risk of developing cancer due to the child's specific diagnosis, and help decide whether this option is in the best interest of the child, and if there are other options to consider (e.g. leaving gonadal tissue in place and monitoring for development of malignancy). If the participant and family have decided to move forward with removal of gonadal tissue for this clinical reason, they will be asked if they would like to have the child participate in this study.
This study seeks to find out if removing gonadal tissue in adolescents and children at risk for losing fertility potential (the ability to have children) and who are scheduled to receive a gonadectomy (removal of gonads) for clinical purposes may preserve, or keep, their ability to have children in the future. Additionally, a primary objective of this study is to use donated research tissue to study long-term ways to preserve and restore reproductive function for children diagnosed with a DSD. Gonadal tissue cryopreservation in patients diagnosed with a DSD is still considered experimental. There have been no reported live births or pregnancies in this population following gonadal tissue cryopreservation at this time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individual < 30 years of age
- •Children diagnosed with a disorder of sex development who have any risk for malignancy in their gonadal tissue or will have their gonads removed for another clinical indication
排除标准
- •Pregnant children
- •Patients likely to retain inherent fertility and reproductive function
- •Children deemed high risk for perioperative complications
- •Patients 12-18 unable to provide assent (i.e. significant psychiatric problems/cognitive delay)
- •Patients 18 and older unable to provide consent (i.e. significant psychiatric problems/cognitive delay)
研究组 & 干预措施
Disorders of Sex Development (DSD)
The study seeks to find out if removing gonadal tissue in adolescents and children at risk for losing fertility potential (the ability to have children) and who are scheduled to receive a gonadectomy (removal of gonads) for clinical purposes may preserve, or keep, their ability to have children in the future. Additionally, donated research tissue would be used to study long-term ways to preserve and restore reproductive function of children diagnosed with DSD
干预措施: Gonadectomy (Procedure)
结局指标
主要结局
Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of Sex Development
时间窗: 3 months
The primary outcome is to evaluate the presence of viable germs cells based on histologic evaluation of the gonads for number of germ cells per high power field and to cryopreserve the tissue.
次要结局
- Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of(yearly, up to 20 years)
- Gonadal Tissue Cryopreservation for Fertility Preservation in Children with Disorders of Sexual Development (DSD)(yearly, up to 20 years)
研究者
Erin Rowell
Director, Fertility & Hormone Preservation & Restoration
Ann & Robert H Lurie Children's Hospital of Chicago
