Reproductive and Mental Health of Patients With Aplastic Anemia

NCT06936930 | Recruiting

• 1 other identifier: QTJC2025034
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aplastic Anemia; Reproductive Health

Keywords

Aplastic Anemia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with abnormal sex hormone levels

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

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

Secondary Outcomes (3)

• Stress levels

  Baseline

• Depression symptoms

  Baseline

• Social support

  Baseline

Study Arms (2)

Female group

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.

Other: Sex hormone monitoring

Male group

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.

Other: Sex hormone monitoring

Interventions

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).

Female group; Male group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Regenerative Medicine Center

Tianjin, Tianjin Municipality, 301617, China

RECRUITING

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases

Central Study Contacts

Jingyu Zhao, MPH

CONTACT

13752253515; zhaojingyu@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)