Clinical trial NCT05667428: A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT
Official title: A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Premature Ovarian Failure
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: POF rate
timeFrame: three years after transplantation
Secondary outcomes:
measure: acute GVHD rate
timeFrame: At day 100 post-transplantation
measure: chronic GVHD rate
timeFrame: 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.
measure: PFS
timeFrame: 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.
measure: OS
timeFrame: 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.
measure: AEs
timeFrame: up to 6 months after HSCT
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Xiaoning Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: