Thermal ablation plus HPV-specific IgY vaginal gel versus watchful waiting in women with histologically confirmed CIN1 and persistent HPV: a prospective observational cohort study.

INTRODUCTION

Persistent human papillomavirus (HPV) infection drives cervical intraepithelial neoplasia (CIN), and over time, a minority of infections progress to cancer. CIN1 typically regresses spontaneously and is usually managed with observation and repeated testing. The role of active treatment for CIN1 remains uncertain. Minimally invasive strategies might enhance lesion regression and HPV clearance. The aim of this study was to evaluate the combined use of cervical thermal ablation and HPV-specific IgY vaginal gel in the treatment of cervical CIN1.

METHODS

In this single-centre prospective observational study (July 2022–July 2024), 237 women with persistent HPV (≥1 year) and histology-confirmed CIN1 chose either treatment (thermal ablation plus a 3-month course of the HPV-specific IgY vaginal gel Lekeduokang; treatment group, TG) or watchful waiting (control group, CG) after counselling (TG n=106; CG n=131). Ablation was performed under colposcopy; follow-up at 6 and 12 months was used to assess lesion regression (composite cytology/histology), HPV clearance, progression to CIN2+, and safety.

RESULTS

At 6 months, regression was greater in the TG than in the CG (53.8%/[57/106] vs. 21.4%/[28/131], P <0.001), with higher HPV clearance (58.5%/[62/106] vs. 18.3%/[24/131], P <0.001). Progression to CIN2+ was uncommon and not significantly different (1.9%/[2/106] vs. 3.8%/[5/131], P =0.47). At 12 months, regression remained greater in the TG (65.1%/[69/106]) than in the CG (35.9%/[47/131], P <0.001), and HPV clearance was greater in the TG (67.9%/[72/106]) than in the CG (35.1%/[46/131], p<0.001). The number of cases with progression was lower in the TG but the difference was not statistically significant (4.7%/[5/106] vs. 8.4%/[11/131], P =0.267). Multivariate analysis revealed that treatment (ablation plus vaginal gel) was significantly related to disease regression at the 12-month follow-up (P=0.003).

CONCLUSION

Thermal ablation plus an HPV-specific IgY vaginal gel was associated with higher 12-month regression and HPV clearance than watchful waiting in women with persistent HPV and CIN1, while progression to CIN2+ did not significantly differ. Given that CIN1 is generally managed with observation and the study’s nonrandomized design, self-selection, single-centre setting, and short follow-up, these findings should be interpreted cautiously. Randomized trials comparing observation, ablation alone, and ablation plus gel with longer follow-up periods are warranted.