Conservative Treatment Therapy, Endometrial Adenocarcinoma, Endometrial Hyperplasia, Fertility Preservation
Conditions
Keywords
Endometrial Cancer, Atypical Endometrial Hyperplasia, Fertility-Sparing Treatment, Hysteroscopy, Progestin Therapy, Reproductive Outcomes
Brief 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.
Detailed description
This is a monocentric cohort study conducted at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. It includes women diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment using standardized hysteroscopic techniques performed by a single surgeon. The intervention consists of hysteroscopic lesion resection, insertion of a 52 mg levonorgestrel-releasing IUD, and in selected cases oral progestin therapy with Megestrol Acetate. The study includes both women desiring fertility preservation and patients medically unfit for radical surgery. Follow-up includes hysteroscopic biopsies at 3, 6, and 12 months. The primary objective is to assess obstetric outcomes, with secondary endpoints including oncologic outcomes.
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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Interval | Up to 12 months after treatment | Evaluation of time without disease recurrence from date of conservative treatment for EAC or AEH. |
Countries
Italy
Contacts
Primary ContactURSULA CATENA
Outcome results
None listed