Reproductive and Mental Health of Patients With Aplastic Anemia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Diagnosis of inherited bone marrow failure syndromes

Combined with other hematological diseases

Chemotherapy-induced bone marrow failure

Pregnant or breastfeeding women

Trial design

Treatments tested in this trial

  • Sex hormone monitoring

Treatment groups

600 Participants
are divided into 2 treatment groups