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NCT Number: NCT07552493

Clinical Study on the Preservation of Ovarian Function Following Autologous Hematopoietic Stem Cell Transplantation Using Goserelin

This study is a prospective, multicenter, randomized controlled clinical trial planned to enroll 64 female hematologic patients aged 14 to 50 years scheduled for autologous hematopoietic stem cell transplantation (auto-HSCT). Participants 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 conditioning regimen for autologous hematopoietic stem cell transplantation primarily employs melphalan. A melphalan dose >140 mg/m² constitutes myeloablative conditioning (MAC), while a dose ≤140 mg/m² is classified as non-myeloablative conditioning. Within each group, patients were randomly assigned 1:1 to the experimental group (goserelin prophylaxis) or control group using a random number table. The experimental group received a single 3.6mg 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 (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; Other reproductive parameters: ovarian and uterine volume, endometrial thickness; time to neutrophil/platelet engraftment; disease recurrence rate; transplant-related mortality; and adverse event (AE) incidence. This study aims to evaluate the efficacy of goserelin in improving ovarian function following autologous hematopoietic stem cell transplantation in hematologic malignancy patients.

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Key information

Conditions

Ovarian Insufficiency Autologous Hematopoietic Stem Cell Transplantation

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

  • Haematological patients scheduled for autologous haematopoietic stem cell transplantation; 2. Female patients aged 14 to 50 years with regular menstrual cycles prior to transplantation; 3. Patients or their legal representatives must voluntarily participate and sign an informed consent form, demonstrating comprehension and willingness to comply with all study procedures and requirements; 4. Estimated survival exceeding one 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 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.

Treatment and study plan

Goserelin 3.6 MG

Drug

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

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), luteinising hormone (LH), and oestradiol (E2) levels; (3) Other reproductive indicators: ovarian and uterine volume, endometrial thickness; (4) Neutrophil/platelet implantation time; (5) Disease recurrence rate; (6) Transplantation-related mortality; (7) 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

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

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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