Clinical Trials Logo

Clinical Trial Summary

The study aims to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in fertile women.


Clinical Trial Description

The introduction of hysteroscopy in clinical practice changed significantly our knowledge of uterine cavity, but did not stimulate the start of big studies with aim to evaluate the feasibility of conservative treatments for better defined diseases as endometrial polyp. The use of curettage(D&C) has led the gynecologists to consider diffuse atypical endometrial hyperplasia and atypical polyp as the same disease. The treatment of these precancerous lesions recommended by scientific societies is aggressive (hysterectomy). Surprisingly, regarding hysterectomy we did not observe management modifications after the introduction of endoscopic techniques, as happened in other surgical disciplines.

To evaluate costs and health benefits of operational hysteroscopy we started in our Institute a study protocol in 1998. In a first trial we studied a conservative treatment of postmenopausal woman with high anesthesiologic risk who had endometrial polyps with atypia and no involvement of the base (Scrimin F. Am J Obstet Gynecol 2006;195:1328-30).

The good initial results and the request of conservative treatments by some women, desiring pregnancies, encouraged us to start this preliminary trial to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in a little sample of fertile women. Other studies suggest progestin treatment of well differentiated carcinoma in young women who desired to preserve their fertility. There is no evidence of a correlation between the tendency to develop endometrial polyps and the risk of endometrial carcinoma. The risk of malignant degeneration of endometrial polyps is not well known, but seems to range between 0.5% and 6%. On this background, we decided to study in the same population of fertile women and with a quasi-randomised design the possible additional effect of levonorgestrel-releasing intrauterine device (LNG-IUD).

Comparison: women assigned to odd numbers underwent polyp resection and endometrial surveillance with insertion of levonorgestrel intrauterine system (IUD group), women assigned to even numbers underwent polyp resection and endometrial surveillance without insertion of levonorgestrel intrauterine system (no IUD or control group). ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00490087
Study type Interventional
Source IRCCS Burlo Garofolo
Contact
Status Completed
Phase Phase 3
Start date January 1999
Completion date March 2007

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02397083 - Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer Phase 2
Recruiting NCT05647109 - Patient-derived Tumor-like Cell Clusters Predict Progesterone Sensitivity in Patients With Early Endometrial Cancer
Completed NCT04491682 - Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia Phase 2/Phase 3
Active, not recruiting NCT00788671 - Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer Phase 2
Completed NCT04385667 - LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia Phase 2/Phase 3
Withdrawn NCT01943058 - Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer Phase 2
Withdrawn NCT04683237 - Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia Phase 2/Phase 3
Completed NCT00483327 - Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate Phase 2
Recruiting NCT05316493 - Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia Phase 2/Phase 3
Completed NCT03241888 - Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia Phase 2/Phase 3
Recruiting NCT06379113 - GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients Phase 2/Phase 3
Recruiting NCT06390904 - GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients Phase 2/Phase 3
Recruiting NCT05316935 - GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients Phase 2/Phase 3
Recruiting NCT05172999 - Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia Phase 2/Phase 3
Recruiting NCT05675787 - Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia Phase 2
Active, not recruiting NCT03671811 - Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy Phase 2
Terminated NCT04607252 - Metformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia Phase 2/Phase 3
Recruiting NCT05051722 - Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Active, not recruiting NCT00892866 - CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells N/A
Recruiting NCT03463252 - Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC Phase 2/Phase 3