Ultrasound and Histology in AEH and Early EEC Treated Conservatively

Condition(s) studied

Investigational drug(s) / intervention(s)

Hysteroscopic fertility-sparing surgery and hormonal treatment: Patients undergo hysteroscopic endometrial resection using the Mazzon "three-step" technique or tissue removal device (TRD), depending on the lesion type. Following surgery, hormonal treatment is administered either via intrauterine device (IUD) or oral progestin. Monitoring includes serial endometrial biopsies and transvaginal ultrasounds at 3, 6, and 12 months.

Study summary

Ultra-S.A.F.E. is a multicenter, ambispective observational study investigating the ultrasound and histological characteristics of patients with atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2 undergoing fertility-sparing treatment (FST). The study aims to describe pre-treatment ultrasound features, evaluate endometrial modifications during treatment, and assess histological and reproductive outcomes. It includes a prospective cohort (new patients recruited at three gynecologic oncology centers) and a retrospective cohort (patients treated conservatively since January 2023). Approximately 50 patients will be enrolled over 24 months, with clinical, ultrasound, and histological data collected. The ultimate goal is to enhance the diagnostic and monitoring role of transvaginal ultrasound (TVUS) in conservative treatment for fertility preservation.

Eligibility

Primary outcome measure(s)

• Transvaginal ultrasound evaluation of the endometrium in patients with AEH or EEC G1-2 before fertility-sparing treatment — Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy.
  Analysis of pre-treatment ultrasound features of the endometrium and/or endometrial lesions, correlating findings with histological data and treatment outcomes.

Trial sites (1)

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy