Surgical Ovarian Preservation in Females Undergoing Chemo-Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 14
- 主要终点
- Resumption of menses
研究概览
简要总结
The purpose of this study is to assess the results of ovarian tissue freezing, such as resumption or initiation of menses (menstruation: the discharge of blood and tissue from the uterus that happens about every 4 weeks in females who are not pregnant) and pregnancy, prior to starting chemotherapy or radiation treatment (commonly used for cancer treatment or for other conditions such as multiple sclerosis, psoriasis, rheumatoid arthritis). Females who are about to undergo chemotherapy or radiation therapy for cancer or these other medical conditions may stop having menses and may not be able to produce a biological child. Girls who have not achieved puberty and are exposed to chemotherapy (alkylating agents) or radiation treatment, the risk is up to 22-50%. In contrast, girls older than 10 years, or who have achieved puberty, experience acute ovarian failure in over 50% of the cases. By freezing and preserving ovarian tissue will help prevent these outcomes. In fact, when you are considered cured of your disease, you will have another surgical procedure where your own ovarian tissue will be transplanted back to you. This surgery will increase the possibility of resuming/initiating menses and the chance to have a pregnancy.
详细描述
At the present time, freezing of ovarian tissue is considered experimental and so thawing and future use of the tissue to initiate a pregnancy must be performed as part of a research program. With the patient's permission, a portion of her ovarian tissue will be frozen for her own use and a portion will be donated to a research pool.
Twenty subjects/year will be participating in this study.
Participation in this study will last until the patient's ovarian tissue is all used, or the patient decides to drop out of the study, or for the rest of her life. Freezing of ovarian tissue can be done only for research. Thawing and future use of the tissue to start a pregnancy must be done as part of a research program. After the age of 18, the patient will decide how and at what institution she wishes to use her own tissue in the future, for the purposes of becoming pregnant. The number of visits will be decided by the surgical procedure performed. The Investigators will contact the patient by phone, email, or mail until she has turned 18 years old, used her tissue or dropped out of the study (whichever comes first) to follow the patient's medical and fertility status over time and to ask questions about any future use of her frozen tissue and the possible results of the treatment. Depending on the patient's age at the time of enrollment, follow-up might be up to 30 years.
PURPOSE Primary objective: To assess resumption/initiation of menses after surgical ovarian preservation (ovarian tissue explant followed by freezing and autologous transplantation).
Secondary objective: To assess pre- and post-treatment production of various hormones, i.e., anti-mullerian hormone (AMH), insulin-like growth factor-1 (IGF-1), inhibin-B, follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol, by serum and histological measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre- and post-pubertal patients who are diagnosed with conditions that necessitate chemo- or radiotherapy and wish to preserve their ovarian function.
- •Exclusion criteria:
- •Patients with acute or chronic conditions that would preclude surgery. These include, but are not limited to, hyper- or hypo-coagulation disorders, lung conditions precluding mechanical ventilation, brain death.
- •Patients for whom the primary oncologist and/or pathologist discourage entering the protocol because of specific condition characteristics. These include, but are not limited to, cancers with high risk of ovarian metastasis such as leukemia and non-Hodgkin lymphoma.
- •Patients with known positive bone marrow for leukemia or solid tumor.
- •Patients whose tumor is in an organ that communicates with the peritoneum and peritoneal sampling at time of primary excision shows evidence of disease.
- •Patients older than 40 years of age.
排除标准
- 未提供
结局指标
主要结局
Resumption of menses
时间窗: Post-op, after initial explant surgery, & one month after, & every 6-12 months until autotransplant of tissue; through 40 yrs of age/menopause (or, pt.decision to stop earlier)
Timing for resumption menses- patient report, physical evaluation at stated intervals.
Fertility
时间窗: Post-op, after initial explant surgery, & one month after, & every 6-12 months until autotransplant of tissue; through 40 yrs of age/menopause (or, pt.decision to stop earlier)
Timing for initiation of pregnancy - patient report, physical evaluation at stated intervals
Initiation of menses
时间窗: Post-op, after initial explant surgery, & one month after, & every 6-12 months until autotransplant of tissue; through 40 yrs of age/menopause (or, pt.decision to stop earlier)
Timing for initiation of menses- patient report, physical evaluation at stated intervals
Completion of puberty
时间窗: Post-op, after initial explant surgery, & one month after, & every 6-12 months until autotransplant of tissue; through 40 yrs of age/menopause (or, pt.decision to stop earlier)
Timing for completion of puberty - patient report, physical evaluation at stated intervals
次要结局
- Physical OVARIAN development(Follow-up at stated intervals, up to 30 years)
- Physical UTERINE development(Follow-up at stated intervals, up to 30 years)