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NCT Number: NCT07552480

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

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.

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Key information

Conditions

Allogeneic Haematopoietic Stem Cell Transplantation Malignant Hematologic Disease Ovarian Insufficiency

Age range

14 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

Goserelin

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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), 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.

Study contacts

Contact information is provided by the study sponsor or research team.

wei Shi

CONTACT

[email protected]

86-13207131315

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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