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NCT Number: NCT07028242

Ultrasound and Histology in AEH and Early EEC Treated Conservatively

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.

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Key information

Conditions

Fertility-Sparing Treatment (FST) Atypical Endometrial Hyperplasia Early Endometrial Cancer (EEC) Endometrial Hyperplasia Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hysteroscopic fertility-sparing surgery and hormonal treatment

Procedure

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.

Other names: Endometrial resection Hormonal therapy Intrauterine device (IUD) placement Oral progestin therapy

Primary outcomes

  1. 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.

    Analysis of pre-treatment ultrasound features of the endometrium and/or endometrial lesions, correlating findings with histological data and treatment outcomes.

Secondary outcomes

  1. Endometrial ultrasound changes during medical treatment

    Time frame: Baseline, 6 months, and 12 months post-treatment initiation.

    Evaluation of ultrasound modifications of the endometrium throughout conservative treatment, correlated with hysteroscopic and histological findings.

  2. Ultrasound predictors of treatment response

    Time frame: Baseline and 6 months post-treatment.

    Comparison of pre-treatment ultrasound features between patients who achieve remission and those with persistent disease after 6 months of therapy.

  3. Endometrial ultrasound characteristics and reproductive success

    Time frame: Baseline and 12 months post-treatment

    Analysis of pre-treatment ultrasound features in patients who achieve pregnancy versus those with negative reproductive outcomes within 12 months of treatment

  4. Correlation between ultrasound and molecular profiling

    Time frame: Baseline

    Investigation of potential associations between endometrial ultrasound characteristics and molecular markers of atypical endometrial hyperplasia or endometrial carcinoma

  5. Comparison of ultrasound and MRI findings

    Time frame: Baseline

    Assessment of ultrasound imaging in comparison to MRI for pre-treatment evaluation of endometrial lesions

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia Carla Testa

CONTACT

[email protected]

0630156399

Federica Pozzati

CONTACT

[email protected]

0630156399

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.

Acronym: ULTRA-SAFE

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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