Goserelin Preserves Ovarian Function in Aplastic Anemia Following Allogeneic HSCT
Summary
This ClinicalTrials.gov registration documents NCT07552506, a prospective randomized multicenter clinical trial investigating whether Goserelin prophylaxis preserves ovarian function in 132 female patients aged 14-50 with severe aplastic anemia undergoing allogeneic hematopoietic stem cell transplantation. Patients will be stratified by busulfan conditioning status and randomized 1:1 to receive a single 3.6 mg subcutaneous Goserelin injection 1-3 days prior to conditioning or standard transplantation regimen without Goserelin. The primary endpoint is menstrual recovery rate at 6 months post-transplant, defined as at least 3 naturally occurring menstrual cycles without intervention by menstrual-regulating drugs.
“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.”
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What changed
The ClinicalTrials.gov entry documents a new prospective randomized controlled multicenter clinical trial (NCT07552506) investigating Goserelin for ovarian preservation in aplastic anemia patients undergoing allogeneic hematopoietic stem cell transplantation. The trial plans to enroll 132 female patients aged 14-50 with severe aplastic anemia, stratifying by busulfan conditioning status and randomizing within each stratum 1:1 to experimental (Goserelin 3.6 mg subcutaneous 1-3 days pre-conditioning) or control groups. Primary outcome is menstrual recovery rate at 6 months; secondary outcomes include POI incidence, ovarian reserve markers (AMH, FSH, LH, E2), reproductive parameters, engraftment time, GVHD rates, and infection rates.
Healthcare providers and clinical investigators involved in stem cell transplantation programs may encounter this trial when managing fertility preservation discussions with female aplastic anemia patients of reproductive age. Sponsors and clinical research organizations considering similar fertility-preservation studies in transplant settings should note the specific inclusion criteria (age 14-50, allo-HSCT candidacy, stratification by busulfan conditioning) and endpoint design when designing comparable trials.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Clinical Study on the Preservation of Ovarian Function in Patients With Aplastic Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation Using Goserelin
N/A NCT07552506 Kind: NA Apr 27, 2026
Abstract
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 ...
Conditions: Aplastic Anaemia (AA), Allogeneic Haematopoietic Stem Cell Transplantation, Ovarian Insufficiency
Interventions: Goserelin Depot
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