Ultrasound and Histology in AEH and Early EEC Treated Conservatively
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hysteroscopic fertility-sparing surgery and hormonal treatment.
- Who it may be relevant to
- Registry conditions: Fertility-Sparing Treatment (FST), Atypical Endometrial Hyperplasia, Early Endometrial Cancer (EEC). Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- Transvaginal ultrasound evaluation of the endometrium in patients with AEH or EEC G1-2 before fertility-sparing treatment [Time frame: Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy.]
Secondary outcome measures (5)
- Endometrial ultrasound changes during medical treatment [Time frame: Baseline, 6 months, and 12 months post-treatment initiation.]
- Ultrasound predictors of treatment response [Time frame: Baseline and 6 months post-treatment.]
- Endometrial ultrasound characteristics and reproductive success [Time frame: Baseline and 12 months post-treatment]
- Correlation between ultrasound and molecular profiling [Time frame: Baseline]
- Comparison of ultrasound and MRI findings [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
Women aged 18-45 years.
Histologically confirmed atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2.
Candidates for fertility-sparing treatment (hysteroscopic resection and/or progestin therapy).
No prior history of invasive endometrial carcinoma.
Adequate endometrial visualization via transvaginal ultrasound (TVUS) and/or MRI.
Signed informed consent for study participation.
Exclusion criteria
Women under 18 or over 45 years.
Presence of myometrial invasion on MRI or histological analysis.
Histological diagnosis of serous carcinoma, clear cell carcinoma, or undifferentiated carcinoma.
History of previous hysterectomy or non-conservative surgical treatment.
Contraindications to hormonal therapy (e.g., thromboembolic disease, hormone-dependent malignancies).
Pregnancy at the time of enrollment.
Lack of adequate imaging for ultrasound-based assessment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Identifiers
NCT: NCT07028242 · 7691