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Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment

Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment

Recruiting
18 years and older
Female
Phase N/A

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Overview

This observational study aims to evaluate the obstetric and oncological outcomes of patients diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Eligible patients include women who received hysteroscopic surgery and hormonal therapy either to preserve fertility or due to medical contraindications to standard radical surgery. Follow-up lasts 12 months.

Description

This is a monocentric cohort study conducted at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. It includes women diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment using standardized hysteroscopic techniques performed by a single surgeon. The intervention consists of hysteroscopic lesion resection, insertion of a 52 mg levonorgestrel-releasing IUD, and in selected cases oral progestin therapy with Megestrol Acetate. The study includes both women desiring fertility preservation and patients medically unfit for radical surgery. Follow-up includes hysteroscopic biopsies at 3, 6, and 12 months. The primary objective is to assess obstetric outcomes, with secondary endpoints including oncologic outcomes.

Eligibility

Inclusion Criteria:

  • Female patients aged 18 years or older.
  • Histological diagnosis of endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH).
  • Patients who underwent conservative treatment with hysteroscopic resection at the CLASS Hysteroscopy Center, performed by a single experienced surgeon (U.C.).
  • Patients treated conservatively due to medical contraindications to radical surgery (e.g., severe comorbidities).
  • Signed informed consent for participation in the study.

Exclusion Criteria:

  • Patients with other known causes of infertility.
  • Patients with non-endometrioid histological subtypes of endometrial adenocarcinoma.
  • Patients under 18 years of age.
  • Patients who did not provide informed consent for participation.

Study details
    Endometrial Adenocarcinoma
    Endometrial Hyperplasia
    Fertility Preservation
    Conservative Treatment Therapy

NCT07077876

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

15 October 2025

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