Hematopoietic Stem Cell TransplantationNCT05667428
A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT
A study testing leuprorelin and normal saline in people with Hematopoietic Stem Cell Transplantation and Premature Ovarian Failure, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
HSCT is an effective method to cure hematologic malignancies. However, the reproductive system is prone to be damaged during radiotherapy and chemotherapy before transplantation, leading to ovarian failure, followed by infertility and premature ovarian failure (POF), which seriously affect the long-term quality of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Premature Ovarian Failure
- What is being tested?
- leuprorelin and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with acute leukemia, MDS, lymphoma, multiple myeloma, SAA and other hematological diseases, with the indications for autologous or allogeneic hematopoietic stem cell transplantation.
- Female, aged 18-45 years.
- Ovarian function was normal before treatment.
- Volunteer to participate in clinical research and sign the informed consent form.
Who cannot join
- No menstruation before treatment, undergone hysterectomy or ovarian surgery.
- Abnormal sexual development.
- Received radiotherapy.
- Combined with tumors affecting gonadal function.
- Deep vein thrombosis.
- Hypertension, liver and/or kidney dysfunction cannot tolerate hematopoietic stem cell transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After Hematopoietic Stem Cell Transplantation
HSCT is an effective method to cure hematologic malignancies. However, the reproductive system is prone to be damaged during radiotherapy and chemotherapy before transplantation, leading to ovarian failure, followed by infertility and premature ovarian failure (POF), which seriously affect the long-term quality of life of patients. This clinical trial aimed to observe the effect of Gonadotropin-releasing hormone analogues (GnRHa) on ovarian function in women of reproductive age after HSCT, so as to provide clinical evidence for whether GnRHa should be used for the prevention of POF.
Read the detailed description
Hematopoietic stem cell transplantation (HSCT) is an effective method for the treatment of hematologic malignancies. However, in the process of radiotherapy and chemotherapy before transplantation, the reproductive system is vulnerable to damage, leading to ovarian failure, which leads to infertility and premature ovarian failure (POF), seriously affecting the long-term quality of life of patients. Exogenous injection of gonadotropin-releasing hormone analogue (GnRHa) has a significant effect on fertility preservation in adolescent and reproductive female patients with breast cancer and cervical cancer. However, there is a lack of large-scale clinical studies on POF in HSCT. Therefore, this clinical trial aimed to observe the effect of GnRHa application before transplantation on ovarian function in women of reproductive age after transplantation, so as to provide clinical evidence for whether GnRHa application for fertility function protection.
- Being tested
- leuprorelin, normal saline
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leuprorelinDrug
Also called GnRHa
From the initial chemotherapy after diagnosis, patients received a subcutaneous injection of leprorelin in each cycle of chemotherapy including the conditioning treatment prior to transplantation.
normal salineDrug
Also called NS
From the initial chemotherapy after diagnosis, patients received a subcutaneous injection of normal saline in each cycle of chemotherapy including the conditioning treatment prior to transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Leprorelin group | Experimental | Leprorelin was given subcutaneously before each cycle of chemotherapy. Receives: Drug: leuprorelin |
| Control group | Placebo comparator | Normal salinewas given subcutaneously before each cycle of chemotherapy. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
POF rate
Incidence of premature ovarian failure after transplantation
Measured: three years after transplantation
Secondary outcomes (5)
acute GVHD rate
the incidence of acute graft-versus-host disease (GVHD)
Measured: At day 100 post-transplantation
chronic GVHD rate
the incidence of chronic graft-versus-host disease (GVHD)
Measured: From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first,assessed up to 36 months.
PFS
Progression Free Survival
Measured: From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months.
OS
Overall Survival
Measured: From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months.
AEs
Adverse reations include abnormalities in bone mineral density, blood glucose, liver and kidney functions.
Measured: up to 6 months after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Mar 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoning Wang, MD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667428
- Sponsor's protocol ID
- XJTU1AF-CRF-2022-XK002
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05667428
- Acronym / sponsor ID
- XJTU1AF-CRF-2022-XK002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HSCT is an effective method to cure hematologic malignancies. However, the reproductive system is prone to be damaged during radiotherapy and chemotherapy before transplantation, leading to ovarian failure, followed by infertility and premature ovarian failure (POF), which seriously affect the long-term quality of life of patients. This clinical trial aimed to observe the effect of Gonadotropin-releasing hormone analogues (GnRHa) on ovarian function in women of reproductive age after HSCT, so as to provide clinical evidence for whether GnRHa should be used for the prevention of POF.
Detailed description
Hematopoietic stem cell transplantation (HSCT) is an effective method for the treatment of hematologic malignancies. However, in the process of radiotherapy and chemotherapy before transplantation, the reproductive system is vulnerable to damage, leading to ovarian failure, which leads to infertility and premature ovarian failure (POF), seriously affecting the long-term quality of life of patients. Exogenous injection of gonadotropin-releasing hormone analogue (GnRHa) has a significant effect on fertility preservation in adolescent and reproductive female patients with breast cancer and cervical cancer. However, there is a lack of large-scale clinical studies on POF in HSCT. Therefore, this clinical trial aimed to observe the effect of GnRHa application before transplantation on ovarian function in women of reproductive age after transplantation, so as to provide clinical evidence for whether GnRHa application for fertility function protection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leprorelin group | Experimental | Drug: leuprorelinLeprorelin was given subcutaneously before each cycle of chemotherapy. |
| Control group | Placebo comparator | Drug: normal salineNormal salinewas given subcutaneously before each cycle of chemotherapy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with acute leukemia, MDS, lymphoma, multiple myeloma, SAA and other hematological diseases, with the indications for autologous or allogeneic hematopoietic stem cell transplantation.
- Female, aged 18-45 years.
- Ovarian function was normal before treatment.
- Volunteer to participate in clinical research and sign the informed consent form.
Key exclusion criteria (6 listed)
- No menstruation before treatment, undergone hysterectomy or ovarian surgery.
- Abnormal sexual development.
- Received radiotherapy.
- Combined with tumors affecting gonadal function.
- Deep vein thrombosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leuprorelinAlso: GnRHaFrom the initial chemotherapy after diagnosis, patients received a subcutaneous injection of leprorelin in each cycle of chemotherapy including the conditioning treatment prior to transplantation. | Drug | Leprorelin group |
| normal salineAlso: NSFrom the initial chemotherapy after diagnosis, patients received a subcutaneous injection of normal saline in each cycle of chemotherapy including the conditioning treatment prior to transplantation. | Drug | Control group |
Primary outcome
POF rate
Time frame: three years after transplantation
Incidence of premature ovarian failure after transplantation
5 secondary outcomes
acute GVHD rate
Time frame: At day 100 post-transplantation
chronic GVHD rate
Time frame: From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first,assessed up to 36 months.
PFS
Time frame: From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months.
OS
Time frame: From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months.
AEs
Time frame: up to 6 months after HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
Related trials for Hematopoietic Stem Cell Transplantation
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Active, not recruitingObservational study
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Bone Marrow Transplant Complications
Not yet recruitingPhase 1
Expanded Donor Stem Cells for Poor Graft Function After Stem Cell Transplantation in Children
Poor Graft Function, Hematopoietic Stem Cell Transplantation Complications
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoning Wang, MD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leuprorelin and normal saline in people with Hematopoietic Stem Cell Transplantation and Premature Ovarian Failure, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoning Wang, MD (0086-18991232608, wangxn99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POF rate (time frame: three years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.