Allogeneic Haematopoietic Stem Cell Transplantation, Aplastic Anaemia (AA), Ovarian Insufficiency
Conditions
Keywords
Aplastic anaemia, Allogeneic haematopoietic stem cell transplantation, Ovarian insufficiency
Brief summary
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.
Interventions
DRUGGoserelin Depot
Subcutaneous injection of 3.6 mg of goserelin acetate once, administered 1 to 3 days prior to allogeneic haematopoietic stem cell transplantation conditioning.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan TongJi Hospital
Zhejiang University
The First Affiliated Hospital of Zhengzhou 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 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.
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), 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. |
Countries
China
Contacts
CONTACTwei shi
Outcome results
None listed