Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of patients who utilize their ovarian tissue and the age at which they use it will be evaluated. The number of patients who elect to have OTC will be analyzed over time to identify trends.
研究概览
简要总结
Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen
详细描述
Cancer is a health concern; however, science advancement in disease detection and treatment modalities continues to improve patient survival rates. Cancer treatment consequences are gaining importance for survivors, families and providers. Infertility is a primary concern among female cancer survivors as it not only has biological implications, but psychosocial implications as well. Cancer treatment can cause acute ovarian failure, premature menopause and results in reproductive challenges in survivorship. Females who are approaching reproductive age at time of cancer diagnosis, who receive abdominopelvic radiation or high dose alkylating agents and those diagnosed with Hodgkin's lymphoma have increased risk for infertility following treatment. Cancer treatment is not the only treatment that threatens reproductive capacity, but rheumatoid arthritis and lupus treatment may also cause infertility.
Female cancer patients express fertility preservation is extremely important for their long-term psychosocial health. The current American Society for Clinical Oncology Clinical Practice Guideline states that all patients should be made aware of possible side effects of treatment on fertility, and that patients be offered fertility preservation interventions. Embryo banking or egg banking (oocyte preservation) prior to chemotherapy is the most successful options for fertility preservation in women. This option necessitates time for ovarian stimulation and retrieval which can take up to 2-3 weeks and is costly. This option may be longer for those who acquire ovarian hyper-stimulation syndrome and younger patients have a higher risk for OHSS. Embryo banking requires mature oocytes and can cause emotional and physical stress. The financial and physical challenges with fertility preservation motivate the desire to find alternatives for young cancer patients.
Improved freezing and thawing techniques for human oocytes have contributed to pregnancy rates comparable to those using fresh egg following in vitro fertilization. Prior to ovarian tissue cryopreservation there was no fertility preservation intervention available to patients who could not delay treatment or were too young to undergo hormonal stimulation. As of 2017, greater than 130 live births following transplantation of frozen/thawed ovarian tissue have been reported. Ovarian tissue cryopreservation has proven to be a safe and efficient method for preserving future fertility for patients undergoing potentially sterilizing treatments. Ovarian tissue cryopreservation is a standard-of-care in parts of Europe and is routine in several children's hospitals throughout the United States. We propose this option be available to qualifying patients at Phoenix Children's Hospital.
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
- 1 Year 至 25 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed or relapsed malignancy with proposed treatment regimen containing at least ONE (1) of the following:
- •whole abdomen or pelvic irradiation
- •total body irradiation
- •Proposed treatment regimen to include any of the following:
- •cyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g/m2
- •any treatment regimen containing procarbazine
- •bone marrow transplant conditioning regimen containing alkylators
- •OR health condition or malignancy that requires removal of one or both ovaries. Health status adequate to undergo elective laparoscopic surgery (as per anesthesiologist assessment)
排除标准
- •Pregnancy or a patient who is currently breastfeeding
- •Patients who are eligible for and agree to oocyte preservation
- •Anyone deemed high risk for complications from the surgery and/or anesthesia.
- •Anyone unable to provide consent due to psychiatric conditions or cognitive delay (in parent/guardian for patients <18 years, and patient >18 years)
研究组 & 干预措施
girls facing possible infertility
Newly diagnosed female or relapsed malignancy who is 1-25 years of age with proposed treatment regimen containing at least ONE (1) of the following:
whole abdomen or pelvic irradiation total body irradiation
Proposed treatment regimen to include any of the following:
cyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g/m2 any treatment regimen containing procarbazine bone marrow transplant conditioning regimen containing alkylator OR health condition or malignancy that requires removal of one or both ovaries
干预措施: Ovarian tissue removal will be performed laparoscopically (Procedure)
结局指标
主要结局
Percentage of patients who utilize their ovarian tissue and the age at which they use it will be evaluated. The number of patients who elect to have OTC will be analyzed over time to identify trends.
时间窗: 10 years
data will be investigated via qualitative analysis.
次要结局
未报告次要终点
