Ultrasound and Histology in AEH and Early EEC Treated Conservatively

NCT07028242 | Not Yet Recruiting

• 1 other identifier: 7691
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fertility-Sparing Treatment (FST); Atypical Endometrial Hyperplasia; Early Endometrial Cancer (EEC)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (pre-treatment), before hysteroscopic surgery and initiation of medical therapy.

Secondary Outcomes (5)

• Endometrial ultrasound changes during medical treatment

  Baseline, 6 months, and 12 months post-treatment initiation.

• Ultrasound predictors of treatment response

  Baseline and 6 months post-treatment.

• Endometrial ultrasound characteristics and reproductive success

  Baseline and 12 months post-treatment

• Correlation between ultrasound and molecular profiling

  Baseline

• Comparison of ultrasound and MRI findings

  Baseline

Study Arms (2)

Retrospective

This group includes patients with a histological diagnosis of atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-G2 who underwent hysteroscopic fertility-sparing surgery and medical treatment starting from January 2023. These patients were retrospectively identified from the Hysteroscopic Treatments Database. Only those with pre-treatment transvaginal ultrasound imaging available were included.

Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment

Prospective

This group includes reproductive-age women newly diagnosed with AEH or EEC G1-G2, confirmed by endometrial biopsy during diagnostic hysteroscopy, who are eligible and consenting for fertility-sparing treatment. Patients undergo baseline clinical assessment, transvaginal ultrasound, and MRI prior to hysteroscopic surgery. Fertility-sparing treatment includes hysteroscopic endometrial resection, intrauterine device (IUD) placement and/or oral progestin therapy, followed by monitoring with serial biopsies and ultrasound at 3, 6, and 12 months.

Procedure: Hysteroscopic fertility-sparing surgery and hormonal treatment

Interventions

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.

Also known as: Endometrial resection Hormonal therapy Intrauterine device (IUD) placement Oral progestin therapy

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The study is limited to female participants, as it investigates conditions affecting the endometrium. Eligibility is determined based on biological sex, rather than gender identity, due to the nature of the pathology and the focus on fertility-sparing treatment in patients with atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2.
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women of reproductive age (18-45 years) diagnosed with atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2, who are eligible for fertility-sparing treatment. Participants are recruited from three gynecologic oncology centers (Rome, Naples, and Turin) and classified into prospective (newly enrolled) and retrospective (previously treated since January 2023) cohorts. The study focuses on analyzing endometrial ultrasound features, assessing response to conservative therapy, and evaluating reproductive outcomes in patients undergoing hysteroscopic resection and/or progestin therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Interventions

Intrauterine Devices

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Study Officials

• Antonia Carla Testa

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Carla Testa

CONTACT

0630156399; antoniacarla.testa@policlinicogemelli.it

Federica Pozzati

CONTACT

0630156399; federica.pozzati@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 11, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

IT (1)