NCT07552480: Goserelin for Ovarian Preservation in Allo-HSCT Patients
Summary
This is a prospective, multicenter, randomized controlled clinical trial registered on ClinicalTrials.gov under identifier NCT07552480, evaluating goserelin for preservation of ovarian function in 64 female patients aged 14-50 with malignant hematologic diseases undergoing allogeneic hematopoietic stem cell transplantation. The study enrolled 64 patients divided by conditioning type (MAC vs. non-MAC), then randomized 1:1 within each group to receive a single 3.6 mg subcutaneous goserelin injection 1-3 days prior to conditioning or no goserelin. The primary endpoint is menstrual recovery rate at 6 months post-transplantation, with secondary endpoints including incidence of premature ovarian insufficiency, ovarian reserve markers (AMH, FSH, LH, E2), ovarian volume, and endometrial thickness.
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What changed
ClinicalTrials.gov registered a new prospective multicenter randomized controlled clinical trial evaluating goserelin as a prophylactic intervention to preserve ovarian function in patients with malignant hematologic diseases undergoing allogeneic hematopoietic stem cell transplantation. The trial enrolled 64 female patients aged 14-50, randomized within MAC and non-MAC conditioning groups to goserelin 3.6 mg or control. Patients receiving goserelin received a single subcutaneous injection 1-3 days prior to conditioning in addition to standard transplantation regimen.
Healthcare providers and clinical investigators involved in hematologic malignancy treatment or fertility preservation programs may encounter this trial as a data source when counseling patients regarding reproductive risks of HSCT. The trial information is informational and does not create new regulatory obligations for manufacturers, healthcare providers, or sponsors.
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 Following Hematopoietic Stem Cell Transplantation in Patients With Malignant Hematologic Diseases Using Goserelin
N/A NCT07552480 Kind: NA Apr 27, 2026
Abstract
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; Ne...
Conditions: Allogeneic Haematopoietic Stem Cell Transplantation, Malignant Hematologic Disease, Ovarian Insufficiency
Interventions: Goserelin
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