Ultrasound and Histology in AEH and Early EEC Treated Conservatively
NCT ID: NCT07028242
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2025-06-11
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
FEMALE
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Antonia Carla Testa
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Countries
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Central Contacts
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Other Identifiers
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7691
Identifier Type: -
Identifier Source: org_study_id
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