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

NCT07552506 · 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

Aplastic Anaemia (AA)Allogeneic Haematopoietic Stem Cell TransplantationOvarian Insufficiency

Investigational drug(s) / intervention(s)

Goserelin Depot

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

Study summary

This study is a prospective, randomized, controlled, multicenter clinical trial. It plans to enroll 132 female SAA patients aged 14-50 years from multiple medical centers nationwide who are scheduled to undergo allo-HSCT. Patients will be divided into two groups based on whether they receive busulfan conditioning: the busulfan-conditioned group (Bu group) and the non-busulfan-conditioned group (non-Bu group). Within each group, patients will be randomly assigned 1:1 to either the experimental group (Goserelin prophylaxis group) or the control group using a random number table. The experimental group will receive 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 will not receive Goserelin prophylaxis. The primary endpoint was menstrual recovery rate at 6 months post-transplant (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; Additional reproductive parameters: ovarian and uterine volume, endometrial thickness; time to neutrophil/platelet engraftment; incidence of acute/chronic graft-versus-host disease (aGVHD/cGVHD), EBV/CMV infection rates; transplant-related mortality; and adverse event (AE) occurrence. This study aims to evaluate the efficacy and safety of goserelin in preserving ovarian function following allo-HSCT.

Eligibility

Sex

FEMALE

Min age

14 Years

Max age

50 Years

Healthy volunteers

Inclusion Criteria: (1) Patients clinically diagnosed with SAA and scheduled for allogeneic haematopoietic 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 comprehension and willingness to comply with all study procedures and requirements; (4) Patients with an estimated survival period exceeding one 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 compromise study outcomes or increase patient risk; (2) Patients with a history of allergy to goserelin or related medications; (3) Patients who have previously undergone menopause due to physiological or pathological factors; (4) Patients with a history of gynaecological 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 influence 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 Following Autologous Hematopoietic Stem Cell Transplantation Using Goserelin Starting soon

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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 NCT07552506 on ClinicalTrials.gov ↗ ← All trials in China