Clinical Study on the Preservation of Ovarian Function Following Hematopoietic Stem Cell Transplantation in Patients With Malignant Hematologic Diseases Using Goserelin

NCT07552480 · tracked via the Priya Life Science China tracker

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Phase

Not applicable

Started

2026-05-01

Last updated

2026-04-27

Condition(s) studied

Allogeneic Haematopoietic Stem Cell TransplantationMalignant Hematologic DiseaseOvarian Insufficiency

Investigational drug(s) / intervention(s)

Goserelin →

Goserelin: Subcutaneous injection of 3.6 mg of goserelin acetate once, administered 1 to 3 days prior to allogeneic haematopoietic stem cell transplantation.

Study summary

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; Neutrophil/platelet engraftment time; Complications: incidence of acute/chronic graft-versus-host disease (aGVHD/cGVHD), EBV/CMV infection rates; Disease recurrence rate; Transplant-related mortality; Adverse event (AE) occurrence. This study aims to evaluate the efficacy and safety of goserelin in improving ovarian function following hematopoietic stem cell transplantation in patients with malignant hematologic diseases.

Eligibility

Sex

FEMALE

Min age

14 Years

Max age

50 Years

Healthy volunteers

Inclusion Criteria: 1\. Patients with malignant hematologic disorders scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT); 2. Female patients aged 14 to 50 years, within reproductive age, with regular menstrual cycles prior to transplantation; 3. Patients or their legal representatives voluntarily participate and sign informed consent forms, demonstrating ability to understand and comply with all study procedures and requirements; 4. Expected survival exceeding 1 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 affect study outcomes or increase patient risk; 2. Patients with a history of allergy to goserelin or other related medications; 3. Patients who have already undergone menopause due to physiological or pathological factors; 4. Patients with a history of gynecological 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 affect menstrual recovery; 6. Patients who refuse to participate in this clinical study.

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)

Facility	City	Region
The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
The First People's Hospital of Yunnan Province	Kunming	Yunnan
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

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Other trials for the same condition

Clinical Study on the Preservation of Ovarian Function in Patients With Aplastic Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation Using Goserelin Starting soon

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07552480 on ClinicalTrials.gov ↗ ← All trials in China