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

February 22, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After Hematopoietic Stem Cell Transplantation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaoning Wang, MD
  • Phone Number: 0086-18991232608
  • Email: wangxn99@163.com

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xian Jiaotong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Leprorelin group
Leprorelin was given subcutaneously before each cycle of chemotherapy.
Drug: leuprorelin
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.
Other Names:
  • GnRHa
Placebo Comparator: Control group
Normal salinewas given subcutaneously before each cycle of chemotherapy.
Drug: normal saline
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.
Other Names:
  • NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POF rate
Time Frame: three years after transplantation
Incidence of premature ovarian failure after transplantation
three years after transplantation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Xiaoning Wang, MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

October 31, 2025

Study Completion (Anticipated)

October 31, 2025

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2022-XK002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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