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

NCT07077876 | Recruiting

• 1 other identifier: 7309
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Adenocarcinoma; Endometrial Hyperplasia; Fertility Preservation; Conservative Treatment Therapy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Pregnancy Rate

  Proportion of participants who achieve a clinical pregnancy (intrauterine gestational sac with fetal heartbeat) after conservative treatment.

  Within 12 months from histologically confirmed complete response

• Miscarriage Rate

  Proportion of pregnancies that end in miscarriage (pregnancy loss \< 20 weeks' gestation) among women who became pregnant after treatment.

  Within 12 months from histologically confirmed complete response

• Live Birth Rate

  Proportion of pregnancies resulting in at least one live-born infant after treatment.

  Within 12 months from histologically confirmed complete response

Secondary Outcomes (1)

• Disease-Free Interval

  Up to 12 months after treatment

Study Arms (1)

Conservatively Treated Patients

Conservatively Treated Patients with Endometrial Cancer and Atypical Endometrial Hyperplasia

Procedure: Hysteroscopic Resection and Hormonal Therapy

Interventions

Hysteroscopic Resection and Hormonal Therapy PROCEDURE

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.

Conservatively Treated Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

RECRUITING

Related Publications (5)

• Catena U, Mirandola M, Capomacchia FM, Fanfani F, Scambia G. A new surgical approach for fertility-sparing management of diffuse endometrial G2 endometrioid adenocarcinoma: a step-by-step technique. Facts Views Vis Obgyn. 2023 Mar;15(1):79-81. doi: 10.52054/FVVO.15.1.058.

  PMID: 37010338 BACKGROUND

• Morice P, Leary A, Creutzberg C, Abu-Rustum N, Darai E. Endometrial cancer. Lancet. 2016 Mar 12;387(10023):1094-1108. doi: 10.1016/S0140-6736(15)00130-0. Epub 2015 Sep 6.

  PMID: 26354523 BACKGROUND

• Jeon YT, Park IA, Kim YB, Kim JW, Park NH, Kang SB, Lee HP, Song YS. Steroid receptor expressions in endometrial cancer: clinical significance and epidemiological implication. Cancer Lett. 2006 Aug 8;239(2):198-204. doi: 10.1016/j.canlet.2005.08.001. Epub 2005 Sep 15.

  PMID: 16168561 BACKGROUND

• Di Spiezio Sardo A, De Angelis MC, Della Corte L, Carugno J, Zizolfi B, Guadagno E, Gencarelli A, Cecchi E, Simoncini T, Bifulco G, Zullo F, Insabato L. Should endometrial biopsy under direct hysteroscopic visualization using the grasp technique become the new gold standard for the preoperative evaluation of the patient with endometrial cancer? Gynecol Oncol. 2020 Aug;158(2):347-353. doi: 10.1016/j.ygyno.2020.05.012. Epub 2020 May 25.

  PMID: 32467056 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Ursula Catena

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

URSULA CATENA

CONTACT

+393382760021; ursula.catena@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 22, 2025
• Study Start: June 20, 2025
• Primary Completion: June 30, 2025
• Study Completion: January 20, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)