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

NCT ID: NCT05667428

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-10-31

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.

Conditions

Hematopoietic Stem Cell Transplantation; Premature Ovarian Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Leprorelin group

Leprorelin was given subcutaneously before each cycle of chemotherapy.

Group Type: EXPERIMENTAL

leuprorelin

Intervention Type: DRUG

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.

Control group

Normal salinewas given subcutaneously before each cycle of chemotherapy.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

GnRHa; NS

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoning Wang, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Xiaoning Wang, MD

Role: CONTACT

wangxn99@163.com

0086-18991232608

Xiaoyan Zheng, MD

Role: CONTACT

xiaoy_2008@126.com

0086-15829370502

Other Identifiers

XJTU1AF-CRF-2022-XK002

Identifier Type: -

Identifier Source: org_study_id