Reproductive and Mental Health of Patients With Aplastic Anemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sex hormone monitoring.
- Who it may be relevant to
- Registry conditions: Aplastic Anemia, Reproductive Health. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study on Reproductive and Psychological Health in Aplastic Anemia Patients
Overview
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.
Interventions
- Other Sex hormone monitoring
Sex hormone monitoring includes the concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), prolactin (PRL), and testosterone (T).
Primary outcome measures
- Proportion of patients with abnormal sex hormone levels [Time frame: Baseline, 6 months post-treatment, 12 months post-treatment]
Secondary outcome measures (3)
- Stress levels [Time frame: Baseline]
- Depression symptoms [Time frame: Baseline]
- Social support [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Regenerative Medicine Center — Tianjin
Identifiers
NCT: NCT06936930 · QTJC2025034