Reproductive and Mental Health of Patients With Aplastic Anemia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jingyu Zhao, MPH
- Phone Number: 13752253515
- Email: zhaojingyu@ihcams.ac.cn
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 301617
- Recruiting
- Regenerative Medicine Center
-
Contact:
- Jingyu Zhao, MPH
- Phone Number: 13752253515
- Email: zhaojingyu@ihcams.ac.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 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 includes the concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), prolactin (PRL), and testosterone (T).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 6 months post-treatment, 12 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress levels
Time Frame: Baseline
|
Perceived Stress Scale (PSS-10) can range from 0 to 40 with higher scores indicating higher perceived stress.
|
Baseline
|
|
Depression symptoms
Time Frame: Baseline
|
Patient Health Questionnaire (PHQ-9) can range from 0 to 27 with higher scores indicating greater severity of depression.
|
Baseline
|
|
Social support
Time Frame: Baseline
|
Medical outcomes study social support survey (MOS-SSS) can range from 0 to 100 with higher scores indicate greater perceived social support.
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QTJC2025034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.