Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
Hysteroscopic 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.
Study 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
Primary outcome measure(s)
- Pregnancy Rate — Within 12 months from histologically confirmed complete response
Proportion of participants who achieve a clinical pregnancy (intrauterine gestational sac with fetal heartbeat) after conservative treatment. - Miscarriage Rate — Within 12 months from histologically confirmed complete response
Proportion of pregnancies that end in miscarriage (pregnancy loss \< 20 weeks' gestation) among women who became pregnant after treatment. - Live Birth Rate — Within 12 months from histologically confirmed complete response
Proportion of pregnancies resulting in at least one live-born infant after treatment.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | Italy | Recruiting |
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07077876 on ClinicalTrials.gov ↗ ← All trials in Italy