Clinical Study on the Preservation of Ovarian Function Following Autologous Hematopoietic Stem Cell Transplantation Using Goserelin

Condition(s) studied

Investigational drug(s) / intervention(s)

Goserelin 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (5)

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

Other trials for the same condition