Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title:
Brief Summary: A prospective multicenter trial has been started in Korea to evaluate the diagnostic accuracy of endometrial aspiration biopsy compared with D&C in patients treated with progestin for endometrial hyperplasia (EH). For conservative treatment of EH, oral progestins are most commonly used method with various treatment regimens and more recently, the levonorgestrel-releasing intrauterine system (LNG-IUS) also has been used successfully to treat EH. However, there is no report about the accuracy of endometrial sampling during hormonal treatment for follow-up evaluation of EH. Patients with histologically confirmed EH are offered hormonal treatment, one of the following 3 options: oral medroxyprogesterone acetate(MPA) 10mg/day for 14days per cycle, continuous oral MPA 10mg/day, or insertion of LNG-IUS. Histological surveillance is performed at 3-months or 6-months following initial treatment. Endometrial tissues are obtained via endometrial aspiration biopsy using a pipelle and D&C. In case of using LNG-IUS, endometrial aspiration biopsy will be done with LNG-IUS in uterus and then, after removal of LNG-IUS, D&C will be done. The biopsy findings will be compared. The primary endpoint is the consistency of the results of the endometrial aspiration biopsy and D&C. The secondary endpoint is the response rate with 3 types of progestin treatment at 6 months.