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.
Study Type
OBSERVATIONAL
Enrollment
50
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Transvaginal ultrasound evaluation of the endometrium in patients with AEH or EEC G1-2 before fertility-sparing treatment
Analysis of pre-treatment ultrasound features of the endometrium and/or endometrial lesions, correlating findings with histological data and treatment outcomes.
Time frame: Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy.
Endometrial ultrasound changes during medical treatment
Evaluation of ultrasound modifications of the endometrium throughout conservative treatment, correlated with hysteroscopic and histological findings.
Time frame: Baseline, 6 months, and 12 months post-treatment initiation.
Ultrasound predictors of treatment response
Comparison of pre-treatment ultrasound features between patients who achieve remission and those with persistent disease after 6 months of therapy.
Time frame: Baseline and 6 months post-treatment.
Endometrial ultrasound characteristics and reproductive success
Analysis of pre-treatment ultrasound features in patients who achieve pregnancy versus those with negative reproductive outcomes within 12 months of treatment
Time frame: Baseline and 12 months post-treatment
Correlation between ultrasound and molecular profiling
Investigation of potential associations between endometrial ultrasound characteristics and molecular markers of atypical endometrial hyperplasia or endometrial carcinoma
Time frame: Baseline
Comparison of ultrasound and MRI findings
Assessment of ultrasound imaging in comparison to MRI for pre-treatment evaluation of endometrial lesions
Time frame: Baseline
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