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

April 20, 2026 updated by: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • The First People's Hospital of Yunnan Province
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Goserelin group
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual recovery rate six months after transplantation
Time Frame: month 6
Menstrual recovery rate at 6 months post-transplant, defined as the natural restoration of menstrual cycles ≥3 times without pharmacological intervention.
month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian function; Safety
Time Frame: 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), luteinising hormone (LH), and oestradiol (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) Adverse event (AE) occurrence; (7) Transplant-related mortality.
month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

The First Affiliated Hospital of Zhengzhou University
Zhejiang University
Wuhan TongJi Hospital
The First People's Hospital of Yunnan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCT260113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Insufficiency

Clinical Trials on Goserelin Depot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe