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

This trial does not accept healthy volunteers

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 population

300 Reproductive-age males and 300 females diagnosed with acquired aplastic anemia.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Sex hormone monitoring

    Other intervention

    Sex hormone monitoring includes the concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), prolactin (PRL), and testosterone (T).

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Female group1 intervention
Group B: Male group1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with abnormal sex hormone levels

The concentrations of FSH, LH, E2, P, PRL and T.

Time frame
Baseline, 6 months post-treatment, 12 months post-treatment

Secondary outcomes

1

Stress levels

Perceived Stress Scale (PSS-10) can range from 0 to 40 with higher scores indicating higher perceived stress.

Time frame
Baseline
2

Depression symptoms

Patient Health Questionnaire (PHQ-9) can range from 0 to 27 with higher scores indicating greater severity of depression.

Time frame
Baseline
3

Social support

Medical outcomes study social support survey (MOS-SSS) can range from 0 to 100 with higher scores indicate greater perceived social support.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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