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| Name | Class |
|---|---|
| Wuhan TongJi Hospital | OTHER |
| Zhejiang University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The First People's Hospital of Yunnan |
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This study is a prospective, randomized, controlled, multicenter clinical trial. It plans to enroll 132 female SAA patients aged 14-50 years from multiple medical centers nationwide who are scheduled to undergo allo-HSCT. Patients will be divided into two groups based on whether they receive busulfan conditioning: the busulfan-conditioned group (Bu group) and the non-busulfan-conditioned group (non-Bu group). Within each group, patients will be randomly assigned 1:1 to either the experimental group (Goserelin prophylaxis group) or the control group using a random number table. The experimental group will receive a single 3.6 mg subcutaneous injection of Goserelin 1-3 days prior to conditioning, in addition to the standard transplantation regimen. The control group will not receive Goserelin prophylaxis. The primary endpoint was menstrual recovery rate at 6 months post-transplant (defined as ≥3 naturally occurring menstrual cycles without intervention by menstrual-regulating drugs). Secondary endpoints included: incidence of premature ovarian insufficiency (POI); ovarian reserve function markers: anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) levels; Additional reproductive parameters: ovarian and uterine volume, endometrial thickness; time to neutrophil/platelet engraftment; incidence of acute/chronic graft-versus-host disease (aGVHD/cGVHD), EBV/CMV infection rates; transplant-related mortality; and adverse event (AE) occurrence. This study aims to evaluate the efficacy and safety of goserelin in preserving ovarian function following allo-HSCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goserelin group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goserelin Depot | Drug | Subcutaneous injection of 3.6 mg of goserelin acetate once, administered 1 to 3 days prior to allogeneic haematopoietic stem cell transplantation conditioning. |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual recovery rate six months after transplantation | Menstrual recovery rate at 6 months post-transplant, defined as the natural restoration of menstrual cycles ≥3 times without pharmacological intervention. | month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian function; Safety | (1) Incidence of premature ovarian insufficiency (POI), defined as FSH > 25 U/L; (2) Ovarian reserve function indicators: anti-Müllerian hormone (AMH) levels, follicle-stimulating hormone (FSH), luteinising hormone (LH), and oestradiol (E2) levels; (3) Other reproductive indicators: ovarian and uterine volume, endometrial thickness; (4) Neutrophil/platelet engraftment time; (5) Incidence of acute/chronic graft-versus-host disease (aGVHD/cGVHD) and Epstein-Barr virus/cytomegalovirus (EBV/CMV) infection rates; (6) Adverse event (AE) occurrence; (7) Transplant-related mortality. |
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Inclusion Criteria:
(1) Patients clinically diagnosed with SAA and scheduled for allogeneic haematopoietic stem cell transplantation (allo-HSCT); (2) Female patients aged 14 to 50 years, within reproductive age, with regular menstrual cycles prior to transplantation; (3) Patients or their legal representatives voluntarily participate and sign informed consent forms, demonstrating comprehension and willingness to comply with all study procedures and requirements; (4) Patients with an estimated survival period exceeding one year to ensure sufficient time for monitoring menstrual recovery.
Exclusion Criteria:
(1) Patients with severe dysfunction of vital organs such as the heart, liver, or kidneys, which may compromise study outcomes or increase patient risk; (2) Patients with a history of allergy to goserelin or related medications; (3) Patients who have previously undergone menopause due to physiological or pathological factors; (4) Patients with a history of gynaecological conditions (e.g., polycystic ovary syndrome, endometriosis) that may interfere with the assessment of menstrual recovery; (5) Patients currently participating in other clinical studies that may influence menstrual recovery; (6) Patients who refuse to participate in this clinical study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wei shi | Contact | 86-13207131315 | 496020121@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
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| OTHER |
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| month 6 |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
|
| The First People's Hospital of Yunnan Province | Kunming | Yunnan | 650000 | China |
|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
|
| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
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