Allogeneic Haematopoietic Stem Cell Transplantation, Malignant Hematologic Disease, Ovarian Insufficiency
Conditions
Keywords
Malignant Hematologic Diseases, Allogeneic haematopoietic stem cell transplantation, Ovarian insufficiency
Brief summary
This study is a prospective, multicenter, randomized controlled clinical trial planned to enroll 64 female patients with malignant hematologic diseases aged 14-50 years who are scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT). Patients will be divided into two groups based on the use of myeloablative conditioning: the myeloablative conditioning (MAC) group and the non-MAC conditioning group. The non-MAC group refers to a primary conditioning regimen where the main conditioning agents-busulfan (Bu) ≤ 6.4 mg/kg, melphalan (Mel) ≤ 140 mg/m², and thiotepa ≤ 10 mg/kg-are combined. Patients receiving this primary chemotherapy regimen will be assigned to the MAC group. Within each group (MAC or non-MAC), patients were randomly assigned 1:1 to either the experimental group (goserelin prophylaxis) or the control group using a random number table. The experimental group received 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 did not receive goserelin prophylaxis. The primary endpoint was menstrual recovery rate at 6 months post-transplantation. 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; other reproductive indicators: ovarian volume, endometrial thickness; Neutrophil/platelet engraftment time; Complications: incidence of acute/chronic graft-versus-host disease (aGVHD/cGVHD), EBV/CMV infection rates; Disease recurrence rate; Transplant-related mortality; Adverse event (AE) occurrence. This study aims to evaluate the efficacy and safety of goserelin in improving ovarian function following hematopoietic stem cell transplantation in patients with malignant hematologic diseases.
Interventions
DRUGGoserelin
Subcutaneous injection of 3.6 mg of goserelin acetate once, administered 1 to 3 days prior to allogeneic haematopoietic stem cell transplantation.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan TongJi Hospital
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Zhejiang University
The First People's Hospital of Yunnan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1\. Patients with malignant hematologic disorders scheduled for allogeneic hematopoietic 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 ability to understand and comply with all study procedures and requirements; 4. Expected survival exceeding 1 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 affect study outcomes or increase patient risk; 2. Patients with a history of allergy to goserelin or other related medications; 3. Patients who have already undergone menopause due to physiological or pathological factors; 4. Patients with a history of gynecological 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 affect menstrual recovery; 6. Patients who refuse to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual recovery rate six months after transplantation | month 6 | Menstrual recovery rate at 6 months post-transplant, defined as the natural restoration of menstrual cycles ≥3 times without pharmacological intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian function; Safety | month 6 | (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), luteinizing hormone (LH), estradiol (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) Disease recurrence rate; (7) Transplant-related mortality; (8) Adverse event (AE) occurrence. |
Countries
China
Contacts
CONTACTwei Shi
Outcome results
None listed