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

Fertility Preservation Endometrial Adenocarcinoma Endometrial Hyperplasia Conservative Treatment Therapy

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

Plain Language Summary

Simplified for easier understanding

This study is reviewing the surgical and fertility outcomes of women with early-stage endometrial cancer (uterine cancer) or atypical endometrial hyperplasia (a precancerous thickening of the uterine lining) who chose or needed conservative (uterus-preserving) treatment instead of full surgery. **You may be eligible if...** - You are a female patient 18 years or older - You have been diagnosed with endometrial adenocarcinoma or atypical endometrial hyperplasia by tissue examination - You were treated with hysteroscopic (minimally invasive) surgery at the CLASS Hysteroscopy Center - You chose conservative treatment because of a desire to preserve fertility, OR because major surgery was too risky due to other health conditions - You signed informed consent to be part of the study **You may NOT be eligible if...** - You have other known causes of infertility - Your cancer is a non-endometrioid type (a less common subtype) - You are under 18 years old - You did not consent to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.