Effect of Imatinib Mesylate on the Ovarian Reserves of Female Patients with Chronic Myeloid Leukaemia

Purpose: Imatinib mesylate (IM) has transformed the treatment of chronic myeloid leukaemia (CML). The improved life expectancy of CML patients has led to increased attention to the adverse effects of the drug. There are conflicting reports of the impact of IM on the female reproductive system. A few studies suggested that IM may reduce ovarian reserve and cause menstrual irregularities in female patients. We systematically looked at the effect of IM on the female reproductive system in a case-control study. Methodology: The study was conducted in the outpatient clinics of the Department of Obstetrics and Gynaecology and the Haematology Clinic. We enrolled 44 patients with CML chronic phase (CML-CP) who had been taking IM for at least one year and 24 patients who had been newly diagnosed with CML CP but had not yet started treatment with IM. CML CP was diagnosed through bone marrow examination and the detection of BCR-ABL transcripts via polymerase chain reaction (PCR). We administered a structured questionnaire to obtain demographic information, menstrual and sexual history, and age at menopause from all patients who had not yet reached menopause at the time of recruitment. We evaluated the effects of IM on menstrual pattern and ovarian reserve using quantitative and qualitative measures, including menstrual cycle characteristics, antral follicle count (AFC), and Anti-Mullerian hormone (AMH) levels in both groups of patients. A transvaginal ultrasound was performed between days 2–5 of the menstrual cycle to determine AFC. AMH levels were tested in the serum of menstruating patients among both cases (n = 30) and controls (n = 19). These variables were compared between both groups to determine the association between IM use and ovarian reserve. Results: The median age of the cases was 40.5 years (range: 22.0–71.0), while the control population had a median age of 35.5 years (range: 22.0–60.0). The median duration of IM therapy was 2.5 years, with a range of 1–15 years. After excluding patients who had already reached menopause at the time of recruitment, there was no significant difference in AMH levels (3.00 ± 5.43 ng/mL in cases versus 4.38 ± 4.69 ng/mL in controls; p = 0.154) or AFC (4.97 ± 3.31 in cases versus 6.16 ± 3.50 in controls; p = 0.219). Similarly, the two groups had no significant difference in menstrual cycle characteristics. However, the age at menopause was significantly lower in patients taking IM for at least one year (except for three women who had already reached menopause before starting imatinib), compared to the control group (41.00 ± 3.46 years versus 47.80 ± 2.49 years, p = 0.006). Conclusion: The study found no significant differences in ovarian reserve parameters, as measured by menstrual cycle characteristics, AMH levels, and antral follicle count, between CML patients receiving IM therapy and newly diagnosed patients who had not yet started treatment. However, our findings highlight the potential risk of early iatrogenic menopause in patients receiving IM therapy, indicating the need for further investigation through larger studies.