Objective To explore the overall diagnostic performance of the International Ovarian Tumor Analysis (IOTA) in combination with carbohydrate antigen 125 (CA125) or human epididymis protein 4 (HE4) for female adnexal tumors.

Methods From January 2017 to July 2020, 140 female patients with suspected adnexal masses who underwent transabdominal ultrasound or transvaginal color Doppler ultrasound in the Ultrasound Department of Zhongshan Hospital, Fudan University were retrospectively selected. The diagnostic performance of IOTA simple rule combined with CA125 or HE4 for 164 adnexal masses was compared; the subgroup analysis of premenopausal and postmenopausal patients was performed to compare the difference in diagnostic performance of the two combined strategies in premenopausal and postmenopausal subgroups.

Results A total of 140 masses were able to use the IOTA simple rule. If 24 uncertain masses were judged as malignant, there was no significant difference in sensitivity (97.3% vs 97.5%), while the specificity decreased significantly (89.4% vs 71.1%, P＜0.05), and the Youden index decreased significantly from 0.87 to 0.69 (P＜0.05). There was no significant difference in sensitivity between IOTA simple rule combined with HE4 and CA125 (95.1 vs 96.3%), but the specificity (90.4% vs 80.7%) and Youden index (0.85 vs 0.77) of the former were significantly higher than those of the latter (P＜0.05). There was no significant difference in diagnostic performance between the two combined strategies in premenopausal and postmenopausal subgroups.

Conclusion IOTA simple rule combined with HE4 has a good diagnostic performance for adnexal masses, which is better than IOTA simple rule combined with CA125, and can help inexperienced examiners to improve the overall diagnostic performance.