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NCT07028242: ULTRA-SAFE
Ultrasound and Histology in AEH and Early EEC Treated Conservatively
trial testing Hysteroscopic fertility-sparing surgery and hormonal treatment in Fertility-Sparing Treatment (FST) in 50 participants. Not yet recruiting.
30 December 2025
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 11 June 2025 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 June 2027 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Hysteroscopic fertility-sparing surgery and hormonal treatment
Conditions studied
- Fertility-Sparing Treatment (FST) — all drugs for Fertility-Sparing Treatment (FST) →
- Atypical Endometrial Hyperplasia — all drugs for Atypical Endometrial Hyperplasia →
- Early Endometrial Cancer (EEC) — all drugs for Early Endometrial Cancer (EEC) →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
Adults 18 to 45, female only, with Fertility-Sparing Treatment (FST) or Atypical Endometrial Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07028242
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07028242 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 19 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07028242.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing