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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sex hormone monitoring | Other | Sex hormone monitoring includes the concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), prolactin (PRL), and testosterone (T). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with abnormal sex hormone levels | The concentrations of FSH, LH, E2, P, PRL and T. | Baseline, 6 months post-treatment, 12 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Stress levels | Perceived Stress Scale (PSS-10) can range from 0 to 40 with higher scores indicating higher perceived stress. | Baseline |
| Depression symptoms | Patient Health Questionnaire (PHQ-9) can range from 0 to 27 with higher scores indicating greater severity of depression. |
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Inclusion Criteria:
Exclusion Criteria:
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300 Reproductive-age males and 300 females diagnosed with acquired aplastic anemia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingyu Zhao, MPH | Contact | 13752253515 | zhaojingyu@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regenerative Medicine Center | Recruiting | Tianjin | Tianjin Municipality | 301617 | China |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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| 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. | Baseline |
| D001855 | Bone Marrow Diseases |