Focused ultrasound ablation for women with cervical lesions: protocol of a randomized controlled trial

Objective: Persistent high-risk human papillomavirus (HPV) infection causes precancerous cervical lesions with subsequent progression to cervical cancer. HPV infection is very common in women of childbearing age, particularly with early onset of sexual activity. Treatments such as cold knife conization are usually used for women of childbearing age with cervical intraepithelial neoplasia 2+, which may cause delayed fertility, cervical insufficiency, and other adverse pregnancy outcomes during subsequent pregnancies. Methods: Focused ultrasound (FUS) is a non-ionizing, non-invasive treatment method used to treat gynecological conditions such as cervicitis and vulvovaginal disease. Results: A protocol has been developed to evaluate the value of FUS in the treatment of women of childbearing age with cervical lesions with fertility preservation. Conclusion: This study aimed to evaluate the therapeutic effect of FUS treatment and fertility protection in women of childbearing age with cervical lesions who require family planning. Trial registration number: Chinese Clinical Trial Registry (ChiCTR2300076739).