Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Conservative management with regular follow-up
  • Conization

Treatment groups

200 Participants
are divided into 2 treatment groups