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Not yet recruiting NCT07552480

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

No phase Interventional Allogeneic Haematopoietic Stem Cell Transplantation Malignant Hematologic Disease Ovarian Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Goserelin.
Who it may be relevant to
Registry conditions: Allogeneic Haematopoietic Stem Cell Transplantation, Malignant Hematologic Disease, Ovarian Insufficiency. Basic parameters: 14 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Menstrual recovery rate six months after transplantation [Time frame: month 6]
Secondary outcome measures (1)
  • Ovarian function; Safety [Time frame: month 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 5 centers
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • The First People's Hospital of Yunnan Province — Kunming
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07552480 · UHCT260114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗