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

NCT07552480 — Not applicable, Not yet recruiting, 64 participants, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07552480
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	64 (Estimated)
Sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Other); collaborators: Wuhan TongJi Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Zhejiang University, The First People's Hospital of Yunnan
Conditions	Allogeneic Haematopoietic Stem Cell Transplantation, Malignant Hematologic Disease, Ovarian Insufficiency
Interventions	Goserelin (Drug)
Dates	start 2026-05-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-04-27, last updated 2026-04-27
Locations	5 sites in China

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Goserelin group	Experimental	Drug: Goserelin
Control group	No intervention

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

+Outcome measures

Primary outcomes

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.

Secondary outcomes

Ovarian function; Safety [month 6]: (1) Incidence of premature ovarian insufficiency (POI), defined as FSH > 25 U/L; (2) Ovarian reserve function indicators: Anti-Müllerian hormone (AMH) levels, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) levels; (3) Other reproductive indicators: Ovarian and uterine volume, endometrial thickness; (4) Neutrophil/platelet engraftment time; (5) Incidence of acute/chronic graft-versus-host disease (aGVHD/cGVHD) and Epstein-Barr virus/cytomegalovirus (EBV/CMV) infection rates; (6) Disease recurrence rate; (7) Transplant-related mortality; (8) Adverse event (AE) occurrence.

+Eligibility

Sex: Female, ages: 14 Years to 50 Years

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.

+Locations (5)

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