A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- POF rate
研究概览
简要总结
HSCT is an effective method to cure hematologic malignancies. However, the reproductive system is prone to be damaged during radiotherapy and chemotherapy before transplantation, leading to ovarian failure, followed by infertility and premature ovarian failure (POF), which seriously affect the long-term quality of life of patients. This clinical trial aimed to observe the effect of Gonadotropin-releasing hormone analogues (GnRHa) on ovarian function in women of reproductive age after HSCT, so as to provide clinical evidence for whether GnRHa should be used for the prevention of POF.
详细描述
Hematopoietic stem cell transplantation (HSCT) is an effective method for the treatment of hematologic malignancies. However, in the process of radiotherapy and chemotherapy before transplantation, the reproductive system is vulnerable to damage, leading to ovarian failure, which leads to infertility and premature ovarian failure (POF), seriously affecting the long-term quality of life of patients. Exogenous injection of gonadotropin-releasing hormone analogue (GnRHa) has a significant effect on fertility preservation in adolescent and reproductive female patients with breast cancer and cervical cancer. However, there is a lack of large-scale clinical studies on POF in HSCT. Therefore, this clinical trial aimed to observe the effect of GnRHa application before transplantation on ovarian function in women of reproductive age after transplantation, so as to provide clinical evidence for whether GnRHa application for fertility function protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with acute leukemia, MDS, lymphoma, multiple myeloma, SAA and other hematological diseases, with the indications for autologous or allogeneic hematopoietic stem cell transplantation.
- •Female, aged 18-45 years.
- •Ovarian function was normal before treatment.
- •Volunteer to participate in clinical research and sign the informed consent form.
排除标准
- •No menstruation before treatment, undergone hysterectomy or ovarian surgery.
- •Abnormal sexual development.
- •Received radiotherapy.
- •Combined with tumors affecting gonadal function.
- •Deep vein thrombosis.
- •Hypertension, liver and/or kidney dysfunction cannot tolerate hematopoietic stem cell transplantation.
研究组 & 干预措施
Leprorelin group
Leprorelin was given subcutaneously before each cycle of chemotherapy.
干预措施: leuprorelin (Drug)
Control group
Normal salinewas given subcutaneously before each cycle of chemotherapy.
干预措施: normal saline (Drug)
结局指标
主要结局
POF rate
时间窗: three years after transplantation
Incidence of premature ovarian failure after transplantation
次要结局
- chronic GVHD rate(From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first,assessed up to 36 months.)
- acute GVHD rate(At day 100 post-transplantation)
- PFS(From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months.)
- OS(From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months.)
- AEs(up to 6 months after HSCT)