The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence

Not Applicable

Not yet recruiting

• Conditions: Endometrial Polyp
• Interventions: Drug: Levonorgestrel Intrauterine System (LNG-IUS)

• Registration Number: NCT06620939
• Lead Sponsor: Zhang Jian

Brief Summary

The goal of this clinical trial is to determine whether the LNG-IUS is more effective to that of expectant in preventing endometrial polyp recurrence after hysteroscopic polypectomy.

Researchers will compare LNG-IUS to expectant management to see if LNG-IUS works to reduce the recurrence rate of endometrial polyps.

Participants will:

Receive Mirena placement or not after hysteroscopic polypectomy； Be scheduled for a follow-up with TVCD to screen for endometrial polyps recurrence every 6 months.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Study Start: 2024-12-01
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 558

Inclusion Criteria

1. （1）Women age 20 to 48 years old;
2. （2）Previous history of endometrial polypectomy;
3. （3）Postoperative pathology confirmed endometrial polyps；
4. （4）Women without fertility desire within 2 years；
5. （5）Signed informed consent.

Exclusion Criteria

1. （1）Contraindications for a hysteroscopic polypectomy or LNG-IUS or not willing to receive this type surgery；
2. （2）Women who have a positive pregnancy test；
3. （3）A I and II type submucosal uterine leiomyoma, congenital uterine malformation, atypical endometrial polyps, a (suspected) malignancy, atypical endometrial cells, reproductive tract infections；
4. （4）Postoperative pathology confirmed non-endometrial polyps；
5. （5）Postoperative pathology confirmed endometrial proliferative diseases which need hormone drug therapy after surgery；
6. （6）Treatment with hormonal three months before surgery；
7. （7）The uterine cavity is more than 10 cm deep；
8. （8）Women with severe diseases；
9. （9）Women who were enrolled in another clinical study that could potentially impact the objectives of this study prior to their initial visit were excluded.
10. （10）Unable to cooperate with the study procedures for various reasons, such as language comprehension difficulties, mental illness, inability to travel to the study center, or poor compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LNG-IUS group	Levonorgestrel Intrauterine System (LNG-IUS)	Participants will receive Mirena placement after hysteroscopic polypectomy

Primary Outcome Measures

Name	Time	Method
Endometrial polyps recurrence rate	2 years

Secondary Outcome Measures

Name	Time	Method
Side effects and complications	2 years
Visual Analogue Scale (VAS) score for chronic pelvic pain	2 years	The minimum value of this scoring table is 0, and the maximum value is 10. The higher the score, the higher the degree of pain.