Ultrasound and tissue changes in women with atypical endometrial hyperplasia or early endometrial cancer
Describes ultrasound and tissue findings in women treated to preserve fertility.
Plain-language title generated from the registry record
Registry title: Ultrasound and Histology in AEH and Early EEC Treated Conservatively
Key facts
- Where
- Roma, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT07028242, who can take part
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT07028242
- Record updated
- 19 June 2025
- Original description
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.Read full original descriptionShow less
Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.
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.
Inclusion: 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: History of previous hysterectomy or non-conservative surgical treatment; Contraindications to hormonal therapy (e.g., thromboembolic disease, hormone-dependent malignancies); 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; Pregnancy at the time of enrollment; Lack of adequate imaging for ultrasound-based assessment.