About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
Women diagnosed with early-stage endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative hysteroscopic treatment at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS, either for fertility preservation or due to contraindications to radical surgery. All procedures were performed by a single experienced surgeon.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Hysteroscopic Resection and Hormonal Therapy
Procedure/SurgeryPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
Pregnancy Rate
Proportion of participants who achieve a clinical pregnancy (intrauterine gestational sac with fetal heartbeat) after conservative treatment.
Miscarriage Rate
Proportion of pregnancies that end in miscarriage (pregnancy loss \< 20 weeks' gestation) among women who became pregnant after treatment.
Live Birth Rate
Proportion of pregnancies resulting in at least one live-born infant after treatment.
Secondary outcomes
Disease-Free Interval
Evaluation of time without disease recurrence from date of conservative treatment for EAC or AEH.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.