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

Xi'an Jiaotong University

Status: Not yet enrolling

Conditions: Hematopoietic Stem Cell Transplantation; Premature Ovarian Failure

Treatments: Drug: leuprorelin; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05667428

XJTU1AF-CRF-2022-XK002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Leprorelin group

Experimental group

Description:

Leprorelin was given subcutaneously before each cycle of chemotherapy.

Treatment:

Drug: leuprorelin

Control group

Placebo Comparator group

Description:

Normal salinewas given subcutaneously before each cycle of chemotherapy.

Treatment:

Drug: normal saline