A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT

Not Applicable

Not yet recruiting

• Conditions: Hematopoietic Stem Cell Transplantation; Premature Ovarian Failure
• Interventions: Drug: normal saline; Drug: leuprorelin

• Registration Number: NCT05667428
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-12-26
• Study First Posted: 2022-12-28
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23
• Study Start: 2023-03-01
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	normal saline	Normal salinewas given subcutaneously before each cycle of chemotherapy.
Leprorelin group	leuprorelin	Leprorelin was given subcutaneously before each cycle of chemotherapy.

Primary Outcome Measures

Name	Time	Method
POF rate	three years after transplantation	Incidence of premature ovarian failure after transplantation

Secondary Outcome Measures

Name	Time	Method
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.	the incidence of chronic graft-versus-host disease (GVHD)
acute GVHD rate	At day 100 post-transplantation	the incidence of acute graft-versus-host disease (GVHD)
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.	Progression Free Survival
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.	Overall Survival
AEs	up to 6 months after HSCT	Adverse reations include abnormalities in bone mineral density, blood glucose, liver and kidney functions.

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China