Autologous Hematopoietic Stem Cell Transplantation, Ovarian Insufficiency
Conditions
Keywords
Autologous haematopoietic stem cell transplantation, Ovarian insufficiency
Brief summary
This study is a prospective, multicenter, randomized controlled clinical trial planned to enroll 64 female hematologic patients aged 14 to 50 years scheduled for autologous hematopoietic stem cell transplantation (auto-HSCT). Participants 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 conditioning regimen for autologous hematopoietic stem cell transplantation primarily employs melphalan. A melphalan dose \>140 mg/m² constitutes myeloablative conditioning (MAC), while a dose ≤140 mg/m² is classified as non-myeloablative conditioning. Within each group, patients were randomly assigned 1:1 to the experimental group (goserelin prophylaxis) or control group using a random number table. The experimental group received a single 3.6mg 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 (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; Other reproductive parameters: ovarian and uterine volume, endometrial thickness; time to neutrophil/platelet engraftment; disease recurrence rate; transplant-related mortality; and adverse event (AE) incidence. This study aims to evaluate the efficacy of goserelin in improving ovarian function following autologous hematopoietic stem cell transplantation in hematologic malignancy patients.
Interventions
DRUGGoserelin 3.6 MG
Subcutaneous injection of 3.6 mg of goserelin acetate once, administered 1 to 3 days prior to autologous haematopoietic stem cell transplantation conditioning.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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\. Haematological patients scheduled for autologous haematopoietic stem cell transplantation; 2. Female patients aged 14 to 50 years with regular menstrual cycles prior to transplantation; 3. Patients or their legal representatives must voluntarily participate and sign an informed consent form, demonstrating comprehension and willingness to comply with all study procedures and requirements; 4. Estimated survival 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 implantation time; (5) Disease recurrence rate; (6) Transplantation-related mortality; (7) Adverse event (AE) occurrence. |
Countries
China
Contacts
CONTACTwei shi
Outcome results
None listed