RecruitingNCT06936930

Reproductive and Mental Health of Patients With Aplastic Anemia

A Study on Reproductive and Psychological Health in Aplastic Anemia Patients


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

600 participants

Start Date

Mar 3, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

OTHERSex hormone monitoring

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


Locations(1)

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

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NCT06936930


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