Conservative management of high-grade squamous intraepithelial lesions (HSILs) seems safe and justified in young women (\<30 years), but evidence is insufficient on whether it is also advisable for older women.
This study will be conducted to analyze spontaneous HSIL regression rates in women of reproductive age and establish whether conservative HSIL management could be safely recommended to women of childbearing potential, irrespective of age.
This is a single-center prospective observational study that will include consecutive women of reproductive age, referred to a tertiary hospital due to HSIL between March 2021 and December 2025, who prefer conservative management rather than immediate cervical conization.
All patients will be followed-up regularly with colposcopy, cytology, human papillomavirus (HPV) testing and biopsies. In case their lesions progress or HSIL persists after 24 months of follow-up, conization will be indicated. Rates of spontaneous regression or resolution, as well as progression rates, will be assessed. Furthermore, the association between potential predictive factors and HSIL resolution will be analyzed.
Reproductive age and aspirations of future pregnancies
Acceptance of conservative management
Commitment to attend scheduled follow-up visits
Colposcopy with transformation zone (ZT) type 1 or 2 (fully visible squamous-columnar union) with lesion with grade 2 changes visible in its entirety. No endocervical involvement
Pregnancy at first visit or during follow-up.
Immunosuppression (either iatrogenic or due to human immunodeficiency virus (HIV))
Suspected or diagnosed Atypical Glandular Cells (ACG), In Situ Adenocarcinoma (AIS) or Cervical Cancer (CC)
Women referred to the PTGI Unit of a tertiary hospital (Hospital de la Santa Creu i Sant Pau, Barcelona, Spain) with a biopsy-confirmed histological diagnosis of HSIL (CIN2 or CIN3) from February 2021 to December 2025, who meet the inclusion criteria and have freely decided on conservative management, with a minimum follow-up of 2 years and maximum 7.
Cohort
Prospective
Conservative management with regular follow-up
Diagnostic testWomen will be followed-up every 4 months, with colposcopy and cytology at each visit.
Conization
Procedure/SurgeryWomen with progression of HSIL, HSIL persistence after 24 months of follow-up, or that no longer meet the criteria for surveillance will have conization
HSIL regression
Abscence of colposcopic lesion or regression of colposcopic lesion
Cytology
normal, LSIL or ASCUS
Biopsy
normal, LSIL or ASCUS
VPH
negative HPV for the HPV type initially detected
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