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

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05667428
• Other study ID #: XJTU1AF-CRF-2022-XK002
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: October 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Xiaoning Wang, MD
• Phone: 0086-18991232608
• Email: wangxn99[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation
• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POF rate	Incidence of premature ovarian failure after transplantation	three years after transplantation
Secondary	acute GVHD rate	the incidence of acute graft-versus-host disease (GVHD)	At day 100 post-transplantation
Secondary	chronic GVHD rate	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.
Secondary	PFS	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.
Secondary	OS	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.
Secondary	AEs	Adverse reations include abnormalities in bone mineral density, blood glucose, liver and kidney functions.	up to 6 months after HSCT