Uterine Transposition: Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Uterine preservation after transposition to the upper abdomen and replacement in the pelvis
研究概览
简要总结
This prospective nonrandomized multicenter phase I study, will evaluate the feasibility of performing uterine transposition before chemoradiation for rectal cancer and uterine reimplantation after the treatment.
详细描述
Patients with pelvic cancer frequently require radiotherapy, which causes infertility even at low doses. Oocytes are highly sensitive to radiation, as a dose of 2 Gy is able to destroy up to 50% of the oocyte population.
Pelvic radiotherapy with fertility preservation is not yet available for women with pelvic tumors. In such cases, the only options are egg and/or embryo freezing and ovarian transposition (OT), which might preserve reproductive and hormonal function, respectively. While ovarian tissue cryopreservation and transplantation are possible, they are still experimental.
Uterine and adnexal transposition (UT) to the upper abdomen before radiotherapy might protect these organs, and the later repositioning of the uterus into the pelvis after radiotherapy might allow the patients to experience a normal pregnancy.
Methods:
Patients with pelvic cancer who will need pelvic radiation will be offered the possibility to performed the uterine transposition before the radiation therapy and after the treatment the uterus will be replaced in it's natural position. The study period is 2 years or 10 patients, that happens first.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with pelvic cancer and indication for pelvic radiation therapy who have fertility sparing desire.
排除标准
- •Previously documented infertility, ovarian failure or gynecologic cancer.
- •More than 40 yo.
- •Previous oophorectomy
- •Tumor infiltrating uterus or adnexes
- •Presence of peritoneal metastasis
- •Presence of systemic metastasis
- •Previous retroperitoneal radiotherapy
- •Retroperitoneal radiotherapy planned
结局指标
主要结局
Uterine preservation after transposition to the upper abdomen and replacement in the pelvis
时间窗: 6 months
The preservation of the uterus with normal endometrium confirmed by ultra-sound, after the surgery to place it in the upper abdomen and after replacing the uterus back to its normal position.
次要结局
- Morbidity(6 months)
- Cancer recurrence(Through study completion, an average of 2 years)
研究者
Reitan Ribeiro
MD
Hospital Erasto Gaertner