Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Effect of vitrification and slow freeze cryopreservation methods on follicular survival
研究概览
简要总结
This study will compare efficacy of ovarian tissue freezing using slow-freeze versus vitrification methods.
详细描述
The primary objective of this study is to determine the efficacy of ovarian tissue cryopreservation using slow-freeze and vitrification methods in enabling long-term preservation of ovarian function and fertility, in females undergoing treatment that may cause infertility. This study will provide study participants with their own tissue to cryopreserve and reserve for future use and:
- Determine the efficacy of ovarian cryopreservation techniques.
- Provide long-term follow up for patients who have undergone ovarian tissue cryopreservation for participants' own use.
In addition to providing study participants with the future opportunity to use their tissue with the intent to reinstate ovarian function, this study will provide research tissue to the embryology research lab at the Family Fertility Center at Texas Children's Hospital that will be used to:
- Optimize techniques for ovarian tissue cryopreservation of ovarian tissue for use in future retransplantation).
- Investigate factors affecting successful maturation and quality of immature oocytes obtained from ovarian tissue including growth factors, hormones and other culture conditions.
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
- 0 Years 至 42 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female Patients only
- •0-42 years of age.
- •Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy that places the patient at risk for impaired ovarian function and infertility 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 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.
- •Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian(s) must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
排除标准
- •Girls and women with psychological, psychiatric, or other conditions which prevent giving informed consent.
- •Girls and women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
- •Girls and women who are permanently menopausal, as documented by history and FSH levels.
- •Girls and women who are pregnant.
结局指标
主要结局
Effect of vitrification and slow freeze cryopreservation methods on follicular survival
时间窗: 5+ years
Investigators will explore and compare the impact of vitrification and slow freeze cryopreservation methods by evaluating follicular survival using classic histological analysis of follicular morphology.
次要结局
- Live birth rates in patients using cryopreserved ovarian tissue(5+ years)
研究者
Terri Lynn Woodard
Associate Professor
Baylor College of Medicine