Clinical trial NCT06936930: Reproductive and Mental Health of Patients With Aplastic Anemia
Official title: A Study on Reproductive and Psychological Health in Aplastic Anemia Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aplastic Anemia
Reproductive Health
Keywords: Aplastic Anemia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 Reproductive-age males and 300 females diagnosed with acquired aplastic anemia.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with abnormal sex hormone levels
timeFrame: Baseline, 6 months post-treatment, 12 months post-treatment
Secondary outcomes:
measure: Stress levels
timeFrame: Baseline
measure: Depression symptoms
timeFrame: Baseline
measure: Social support
timeFrame: Baseline
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Regenerative Medicine Center
state: Tianjin
Study officials:
References: