Aplastic AnemiaNCT06936930
Reproductive and Mental Health of Patients With Aplastic Anemia
An observational study of Aplastic Anemia and Reproductive Health, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Aplastic anemia (AA) is a hematological disease characterized by bone marrow failure, leading to varying degrees of anemia, leukopenia, and thrombocytopenia. With the advancement of immunosuppressive therapy and hematopoietic stem cell transplantation, the survival of AA patients has significantly improved. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Aplastic Anemia, Reproductive Health
- What is being tested?
- Sex hormone monitoring
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Adult
Study population: 300 Reproductive-age males and 300 females diagnosed with acquired aplastic anemia.
Who may be able to join
- Diagnosis of AA
- Male or female, aged 18-40 years
- ECOG performance status ≤2
- Willing and able to comply with the requirements for this study and written informed consent
Who cannot join
- Diagnosis of inherited bone marrow failure syndromes
- Combined with other hematological diseases
- Chemotherapy-induced bone marrow failure
- Pregnant or breastfeeding women
- Subjects with a history of mental illness or severe psychological disorders
- Subjects with a history of reproductive system cancer (eg, penile cancer, testicular cancer, prostate cancer, ovarian cancer, cervical cancer, vaginal cancer, etc.)
- Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Regenerative Medicine Center
Tianjin, Tianjin Municipality, 301617
Jingyu Zhao, MPH, 13752253515, zhaojingyu@ihcams.ac.cn
About this study
Official title: A Study on Reproductive and Psychological Health in Aplastic Anemia Patients
Aplastic anemia (AA) is a hematological disease characterized by bone marrow failure, leading to varying degrees of anemia, leukopenia, and thrombocytopenia. With the advancement of immunosuppressive therapy and hematopoietic stem cell transplantation, the survival of AA patients has significantly improved. However, these treatment approaches may result in reproductive system impairment.
Reproductive health has been a major concern among reproductive-age AA patients. In female patients, it often manifests as irregular menstruation, amenorrhea, and infertility; while in male patients, it may present as reduced sperm count and low sperm motility. The reproductive impairment observed in AA patients may be attributed to various factors, including the disease's underlying pathophysiology, side effects of used medications such as androgens and the toxicity conditioning agents during transplantation.
Notably, immunosuppressive agents (such as cyclosporine and antithymocyte globulin) and chemotherapeutic drugs (such as cyclophosphamide) can suppress hematopoiesis and directly damage the gonads, thereby impairing reproductive function. Furthermore, long-term use of these medications may disrupt the endocrine system, affecting the secretion of sex hormones and overall reproductive capacity. Additionally, chronic anemia in AA patients can lead to compensatory physiological changes in other body systems, which may also indirectly affect reproductive health.
- Conditions
- Aplastic Anemia, Reproductive Health
- Being tested
- Sex hormone monitoring
- Keywords
- Aplastic Anemia
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sex hormone monitoringOther
Sex hormone monitoring includes the concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), prolactin (PRL), and testosterone (T).
| Study group | Role | What they receive |
|---|---|---|
| Female group | To evaluate the reproductive health and psychological status of reproductive-age patients with aplastic anemia and to monitor long-term changes in sex hormone levels under different treatment regimens. Receives: Other: Sex hormone monitoring | |
| Male group | To evaluate the reproductive health and psychological status of reproductive-age patients with aplastic anemia and to monitor long-term changes in sex hormone levels under different treatment regimens. Receives: Other: Sex hormone monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with abnormal sex hormone levels
The concentrations of FSH, LH, E2, P, PRL and T.
Measured: Baseline, 6 months post-treatment, 12 months post-treatment
Secondary outcomes (3)
Stress levels
Perceived Stress Scale (PSS-10) can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline
Depression symptoms
Patient Health Questionnaire (PHQ-9) can range from 0 to 27 with higher scores indicating greater severity of depression.
Measured: Baseline
Social support
Medical outcomes study social support survey (MOS-SSS) can range from 0 to 100 with higher scores indicate greater perceived social support.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start3 Mar 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936930
- Sponsor's protocol ID
- QTJC2025034
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Reproductive and Psychological Health in Aplastic Anemia Patients
- ClinicalTrials.gov ID
- NCT06936930
- Acronym / sponsor ID
- QTJC2025034
- Conditions
- Aplastic Anemia, Reproductive Health
- Keywords
- Aplastic Anemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Apr 2025 (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.
Aplastic anemia (AA) is a hematological disease characterized by bone marrow failure, leading to varying degrees of anemia, leukopenia, and thrombocytopenia. With the advancement of immunosuppressive therapy and hematopoietic stem cell transplantation, the survival of AA patients has significantly improved. However, these treatment approaches may result in reproductive system impairment.
Reproductive health has been a major concern among reproductive-age AA patients. In female patients, it often manifests as irregular menstruation, amenorrhea, and infertility; while in male patients, it may present as reduced sperm count and low sperm motility. The reproductive impairment observed in AA patients may be attributed to various factors, including the disease's underlying pathophysiology, side effects of used medications such as androgens and the toxicity conditioning agents during transplantation.
Notably, immunosuppressive agents (such as cyclosporine and antithymocyte globulin) and chemotherapeutic drugs (such as cyclophosphamide) can suppress hematopoiesis and directly damage the gonads, thereby impairing reproductive function. Furthermore, long-term use of these medications may disrupt the endocrine system, affecting the secretion of sex hormones and overall reproductive capacity. Additionally, chronic anemia in AA patients can lead to compensatory physiological changes in other body systems, which may also indirectly affect reproductive health.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female group | – | Other: Sex hormone monitoringTo evaluate the reproductive health and psychological status of reproductive-age patients with aplastic anemia and to monitor long-term changes in sex hormone levels under different treatment regimens. |
| Male group | – | Other: Sex hormone monitoringTo evaluate the reproductive health and psychological status of reproductive-age patients with aplastic anemia and to monitor long-term changes in sex hormone levels under different treatment regimens. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- 300 Reproductive-age males and 300 females diagnosed with acquired aplastic anemia.
Key inclusion criteria (4 listed)
- Diagnosis of AA
- Male or female, aged 18-40 years
- ECOG performance status ≤2
- Willing and able to comply with the requirements for this study and written informed consent
Key exclusion criteria (7 listed)
- Diagnosis of inherited bone marrow failure syndromes
- Combined with other hematological diseases
- Chemotherapy-induced bone marrow failure
- Pregnant or breastfeeding women
- Subjects with a history of mental illness or severe psychological disorders
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 |
|---|---|---|
| Sex hormone monitoringSex hormone monitoring includes the concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), prolactin (PRL), and testosterone (T). | Other | Female group, Male group |
Primary outcome
Proportion of patients with abnormal sex hormone levels
Time frame: Baseline, 6 months post-treatment, 12 months post-treatment
The concentrations of FSH, LH, E2, P, PRL and T.
3 secondary outcomes
Stress levels
Time frame: Baseline
Depression symptoms
Time frame: Baseline
Social support
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aplastic Anemia and Reproductive Health, run by Institute of Hematology & Blood Diseases Hospital, China 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 7 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: looking for participants now, as of the sponsor's last update on 5 Aug 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyu Zhao, MPH (13752253515, zhaojingyu@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with abnormal sex hormone levels (time frame: Baseline, 6 months post-treatment, 12 months post-treatment). 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 5 Aug 2025.