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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05667428
Other study ID # XJTU1AF-CRF-2022-XK002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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