Reproductive and Mental Health of Patients With Aplastic Anemia

Institute of Hematology & Blood Diseases Hospital, China

Status: Enrolling

Conditions: Aplastic Anemia; Reproductive Health

Treatments: Other: Sex hormone monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT06936930

QTJC2025034

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

Female group

Description:

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.

Treatment:

Other: Sex hormone monitoring

Male group

Description:

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.

Treatment:

Other: Sex hormone monitoring