Clinical Study on Preservation of Ovarian Function Following Autologous HSCT Using Goserelin
Summary
This ClinicalTrials.gov record describes NCT07552493, a prospective, multicenter, randomized controlled clinical trial investigating goserelin prophylaxis for preservation of ovarian function in 64 female hematologic patients aged 14 to 50 years scheduled for autologous hematopoietic stem cell transplantation (auto-HSCT). Participants are divided into myeloablative conditioning (MAC) and non-MAC groups, then further randomized 1:1 to experimental (goserelin 3.6mg subcutaneous injection 1-3 days prior to conditioning) or control arms. The primary endpoint is menstrual recovery rate at 6 months post-transplantation.
“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).”
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What changed
This is a clinical trial registration record for NCT07552493, a prospective, multicenter, randomized controlled trial. The study evaluates whether a single 3.6mg subcutaneous injection of goserelin administered 1-3 days prior to conditioning chemotherapy preserves ovarian function in female patients aged 14-50 undergoing autologous hematopoietic stem cell transplantation. Participants are stratified by conditioning intensity (melphalan dose >140 mg/m² for myeloablative vs ≤140 mg/m² for non-myeloablative) and randomized 1:1 within each stratum to goserelin prophylaxis or control.
Healthcare providers referring patients for auto-HSCT and patients considering this procedure should note this trial's inclusion criteria and endpoints. The primary endpoint of menstrual recovery at 6 months and secondary endpoints including premature ovarian insufficiency incidence and ovarian reserve markers (AMH, FSH, LH, estradiol) may inform discussions about fertility preservation options for reproductive-age patients undergoing transplant conditioning regimens.
Archived snapshot
Apr 27, 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 Autologous Hematopoietic Stem Cell Transplantation Using Goserelin
N/A NCT07552493 Kind: NA Apr 27, 2026
Abstract
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 uteri...
Conditions: Ovarian Insufficiency, Autologous Hematopoietic Stem Cell Transplantation
Interventions: Goserelin 3.6 MG
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