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Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Recruitingn/aAges any - anyFemaleFundació Institut de Recerca de l'Hospital de la …
NCT04783805 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 2

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Colposcopy with grade 2 changes that are not extensive: \<50% of the cervical surface Exclusion Criteria: * 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)
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What it tests

  • Conservative management with regular follow-up
  • Conization
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Where

1 site
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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