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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
From the initial chemotherapy after diagnosis, patients received a subcutaneous injection of leprorelin in each cycle of chemotherapy including the conditioning treatment prior to transplantation.
From the initial chemotherapy after diagnosis, patients received a subcutaneous injection of normal saline in each cycle of chemotherapy including the conditioning treatment prior to transplantation.
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
POF rate
Incidence of premature ovarian failure after transplantation
Time frame: three years after transplantation
acute GVHD rate
the incidence of acute graft-versus-host disease (GVHD)
Time frame: At day 100 post-transplantation
chronic GVHD rate
the incidence of chronic graft-versus-host disease (GVHD)
Time frame: 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.
PFS
Progression Free Survival
Time frame: 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
Overall Survival
Time frame: 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
Adverse reations include abnormalities in bone mineral density, blood glucose, liver and kidney functions.
Time frame: up to 6 months after HSCT
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