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NCT Number: NCT06936930

Reproductive and Mental Health of Patients With Aplastic Anemia

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Regenerative Medicine Center

Tianjin, Tianjin Municipality, 301617, China

Location status: Recruiting

Location contact

Jingyu Zhao, MPH

CONTACT

[email protected]

13752253515

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sex hormone monitoring

Other

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

Primary outcomes

  1. Proportion of patients with abnormal sex hormone levels

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

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

Secondary outcomes

  1. Stress levels

    Time frame: Baseline

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

  2. Depression symptoms

    Time frame: Baseline

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

  3. Social support

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jingyu Zhao, MPH

CONTACT

[email protected]

13752253515

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

A Study on Reproductive and Psychological Health in Aplastic Anemia Patients

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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