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

Primary Purpose

Hematopoietic Stem Cell Transplantation, Premature Ovarian Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
leuprorelin
normal saline
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematopoietic Stem Cell Transplantation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Leprorelin group

Control group

Arm Description

Leprorelin was given subcutaneously before each cycle of chemotherapy.

Normal salinewas given subcutaneously before each cycle of chemotherapy.

Outcomes

Primary Outcome Measures

POF rate
Incidence of premature ovarian failure after transplantation

Secondary Outcome Measures

acute GVHD rate
the incidence of acute graft-versus-host disease (GVHD)
chronic GVHD rate
the incidence of chronic graft-versus-host disease (GVHD)
PFS
Progression Free Survival
OS
Overall Survival
AEs
Adverse reations include abnormalities in bone mineral density, blood glucose, liver and kidney functions.

Full Information

First Posted
October 27, 2022
Last Updated
February 22, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05667428
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Stem Cell Transplantation, Premature Ovarian Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Leprorelin group
Arm Type
Experimental
Arm Description
Leprorelin was given subcutaneously before each cycle of chemotherapy.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Normal salinewas given subcutaneously before each cycle of chemotherapy.
Intervention Type
Drug
Intervention Name(s)
leuprorelin
Other Intervention Name(s)
GnRHa
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
NS
Intervention Description
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.
Primary Outcome Measure Information:
Title
POF rate
Description
Incidence of premature ovarian failure after transplantation
Time Frame
three years after transplantation
Secondary Outcome Measure Information:
Title
acute GVHD rate
Description
the incidence of acute graft-versus-host disease (GVHD)
Time Frame
At day 100 post-transplantation
Title
chronic GVHD rate
Description
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.
Title
PFS
Description
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.
Title
OS
Description
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.
Title
AEs
Description
Adverse reations include abnormalities in bone mineral density, blood glucose, liver and kidney functions.
Time Frame
up to 6 months after HSCT

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoning Wang, MD
Phone
0086-18991232608
Email
wangxn99@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Zheng, MD
Phone
0086-15829370502
Email
xiaoy_2008@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoning Wang, MD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

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

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