Clinical Study on the Preservation of Ovarian Function in Patients With Aplastic Anemia Following… (NCT07552506) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study on the Preservation of Ovarian Function in Patients With Aplastic Anemia Following Allogeneic Hematopoietic Stem Cell Transplantation Using Goserelin
China132 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
14 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Menstrual recovery rate six months after transplantation
Timeframe: month 6
Trial details
NCT IDNCT07552506
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology