Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary After Cryopreservation of Ovarian Tissue Before Cytotoxic Therapies - Where do More Follicles Grow?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Comparison of follicle maturation in transplanted tissue between pelvic wall and ovary
研究概览
简要总结
The purpose of this study is to determine whether the pelvic wall or the ovary represents a better location for the maturation of follicles in the context of ovarian transplantation after cryopreservation of ovarian tissue before cytotoxic therapies.
详细描述
The development of modern medicine made it more likely for oncological patients to survive. Also, there are a lot of young female patients with a persistent wish for kids. After an aggressive chemotherapy, premature ovarian failure (POF) is a possible consequence of the therapy. Therefore, efficient fertility protective interventions are requested. The transplantation of ovarian tissue after cryopreservation is a valuable method, which could remain fertility after POF induced by cytotoxic therapies. Especially for girls suffering from cancer, who didn't reach puberty yet, cryopreservation of ovarian tissue is the only opportunity to preserve a chance of restoring fertility after POF.
There are two locations, which could be used for the retransplantation of the cryopreserved tissue: the remaining ovary and the pelvic wall. Both, the ovary and the subperitoneal pocket in the pelvic wall present a location, where the maturation of follicles is possible. The remaining question is: where do more follicles grow? To answer this question, a study will be necessary. The purpose of this study is to determine whether the pelvic wall or the ovary represents a better location for the maturation of follicles in the context of ovarian transplantation after cryopreservation of ovarian tissue before cytotoxic therapies.
Interventions:
Ovarian tissue will be transplanted into two different locations; subperitoneal into the loge of the adnexa of uterus and contralateral into the ovary. The assignment of the two parts of ovarian tissue to the place of transplantation (pelvic wall vs. ovary) will be randomised. The study-specific interventions include:
- Transplantation of the same amount of ovarian tissue into both locations
- Monthly sonographic controls and determination of estradiol, LH, FSH and progesterone from the 3rd on to the 12th month after the transplantation. Therefore, blood samples will be made.
- Monthly documentation of the duration of the cycle from the 3rd on to the 12th month after transplantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age at cryopreservation ot tissue max. 38 years
- •Age at transplantation 18-49 years
- •At least one maintained ovary
- •Premature ovarian failure
- •Indication for an autologous transplantation of ovarian tissue
- •Permitted pregnancy from the part of the oncologists
- •Written informed consent
排除标准
- •Age at transplantation <18 and >49 years
- •Cryopreservation in the context of a leucaemia, neuroblastoma, Burkitt-lymphoma
- •Important: Inclusion is only done by one of the recruiting centers. Study participation will only be given on invitation. Please contact Principal Investigator!
结局指标
主要结局
Comparison of follicle maturation in transplanted tissue between pelvic wall and ovary
时间窗: Beginning 3 months after the transplantation until 12 months after the transplantation
The participants will get an assessment of the follicle maturation on both sides (pelvic wall and ovary) each month beginning 3 months after the transplantation until 12 months after the transplantation. Overall, 10 assessments will take place. The maturation of follicles will be detected with sonography and measured in mm. Along with the sonography, blood samples will be taken and examined for their amount of estradiol, FSH and progesterone. A follicle ≥15mm with a concentration of estradiol \>500 pmol/L (\>136pg/ml) is considered a mature follicle. The primary outcome contains the quantitative comparison of mature follicles grown on both sides.
次要结局
- Number of study participants with pregnancy(12 months after transplantation and 24 months after transplantation)
- Sonographic measurement of the endometrium wall, measured in mm(Beginning 3 months after the transplantation until 12 months after the transplantation)
- Duration of cycle, measured in weeks(Beginning 3 months after the transplantation until 12 months after the transplantation)
- Number of study participants with life-birth after pregnancy(12 months after transplantation and 24 months after transplantation)
- Determination of hormone levels after transplantation, concerning the concentration of estradiol, progesterone, LH, FSH(Beginning 3 months after the transplantation until 12 months after the transplantation)