Clinical trial · Observational
Comparison of Dilatation & Curettage and Endometrial Aspiration Biopsy Accuracy in Patients Treated With Progestin for Endometrial Hyperplasia: A Korean Gynecologic Oncology Group Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Hyperplasia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- consistency of the endometrial aspiration biopsy and D&C after hormonal treatment of EH
- timeFrame
- 3months or 6 months
Secondary outcomes (1)
- measure
- response rate
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are histological confirmed as endometrial hyperplasia 2. Patients who desire to preserve fertility potential. 3. Patients signed the written informed consent voluntarily. Exclusion Criteria: 1. Pregnancy or suspected pregnancy. 2. Patients who have severe underlying disease or complication. 3. Treatment for metastatic cancer from other organs or cancer therapy within the preceding 5 years. 4. Congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity. 5. Acute liver disease or kidney disease 6. Thrombosis or phlebothrombosis requiring treatment. 7. Genital (vaginal, uterine or ovarian) infection. 8. Acute severe disease of the arteries, such as stroke or heart infarction, or a history of artery disease. 9. Hypersensitivity to any component of this product.
References
Publications (1)
- DERIVEDKim MK, Seong SJ, Park DC, Hong JH, Roh JW, Kang SB. Comparison of diagnostic accuracy between endometrial curettage and aspiration biopsy in patients treated with progestin for endometrial hyperplasia: a Korean Gynecologic Oncology Group study. J Gynecol Oncol. 2020 Jul;31(4):e51. doi: 10.3802/jgo.2020.31.e51. Epub 2020 Feb 7. PMID 32266800