ClinConnect ClinConnect Logo
Search / Trial NCT07077876

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jul 12, 2025

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Endometrial Cancer Atypical Endometrial Hyperplasia Fertility Sparing Treatment Hysteroscopy Progestin Therapy Reproductive Outcomes

ClinConnect Summary

This clinical trial is studying women diagnosed with early-stage womb (endometrial) conditions called endometrial adenocarcinoma or atypical endometrial hyperplasia. These conditions affect the lining of the uterus and can sometimes be treated without removing the uterus, which is important for women who want to preserve their ability to have children or who cannot undergo major surgery for health reasons. The study focuses on women who have received a conservative treatment that involves a special surgery to remove abnormal tissue through a small camera inserted into the uterus, followed by hormone therapy. The researchers want to learn more about how well this treatment works and whether patients can safely become pregnant afterward.

Women aged 18 or older who have been diagnosed with these specific uterine conditions and who have had this type of conservative treatment performed at the CLASS Hysteroscopy Center in Rome may be eligible to join. Participants will be followed for 12 months to monitor their health and any pregnancy outcomes. It’s important that participants have no other causes of infertility and agree to take part by signing a consent form. This study helps doctors understand the chances of successful pregnancy and cancer control with less invasive treatment options, offering hope for women who need alternatives to standard surgery.

Gender

FEMALE

Eligibility criteria

  • 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Ursula Catena

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported