Reproductive and Mental Health of Patients With Aplastic Anemia
NCT ID: NCT06936930
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2025-03-03
2027-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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).
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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Locations
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Regenerative Medicine Center
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QTJC2025034
Identifier Type: -
Identifier Source: org_study_id
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