Reproductive and Mental Health of Patients With Aplastic Anemia

Recruiting

• Conditions: Aplastic Anemia; Reproductive Health

• Registration Number: NCT06936930
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-03
• Status Verified: 2025-04
• Study First Submitted: 2025-04-13
• Study First Submitted QC: 2025-04-13
• Last Update Submitted: 2025-04-13
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Primary Completion: 2027-10-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with abnormal sex hormone levels	Baseline, 6 months post-treatment, 12 months post-treatment	The concentrations of FSH, LH, E2, P, PRL and T.

Secondary Outcome Measures

Name	Time	Method
Stress levels	Baseline	Perceived Stress Scale (PSS-10) can range from 0 to 40 with higher scores indicating higher perceived stress.
Depression symptoms	Baseline	Patient Health Questionnaire (PHQ-9) can range from 0 to 27 with higher scores indicating greater severity of depression.
Social support	Baseline	Medical outcomes study social support survey (MOS-SSS) can range from 0 to 100 with higher scores indicate greater perceived social support.

Trial Locations

Locations (1)

Regenerative Medicine Center; 🇨🇳 Tianjin, Tianjin, China