RecruitingNCT07077876

Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment

Surgical and Obstetric Outcomes in Patients With Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia Undergoing Conservative Treatment


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

100 participants

Start Date

Jun 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This observational study aims to evaluate the obstetric and oncological outcomes of patients diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Eligible patients include women who received hysteroscopic surgery and hormonal therapy either to preserve fertility or due to medical contraindications to standard radical surgery. Follow-up lasts 12 months.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • Female patients aged 18 years or older.
  • Histological diagnosis of endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH).
  • Patients who underwent conservative treatment with hysteroscopic resection at the CLASS Hysteroscopy Center, performed by a single experienced surgeon (U.C.).
  • Patients treated conservatively due to medical contraindications to radical surgery (e.g., severe comorbidities).
  • Signed informed consent for participation in the study.

Exclusion Criteria4

  • Patients with other known causes of infertility.
  • Patients with non-endometrioid histological subtypes of endometrial adenocarcinoma.
  • Patients under 18 years of age.
  • Patients who did not provide informed consent for participation.

Interventions

PROCEDUREHysteroscopic Resection and Hormonal Therapy

Patients underwent hysteroscopic resection of atypical endometrial hyperplasia (AEH) or grade 1-2 endometrial adenocarcinoma (EAC) using a 15 Fr mini-resectoscope. Depending on the case, the procedure included visual D\&C or a combined technique. At the end of the procedure, a 52 mg levonorgestrel-releasing intrauterine device (LNG-IUD) was inserted. In patients with EAC G2 or poor prognostic markers (e.g., MMR deficiency), oral progestin therapy with Megestrol Acetate (160 mg daily) was added. Follow-up included hysteroscopic endometrial biopsy at 3, 6, and 12 months to assess response.


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

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NCT07077876


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