The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometrial Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Statistician

Study Groups

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LNG-IUS group

Participants will receive Mirena placement after hysteroscopic polypectomy

Group Type EXPERIMENTAL

Levonorgestrel Intrauterine System (LNG-IUS)

Intervention Type DRUG

Participants in the intervention group will receive Mirena placement after hysteroscopic polypectomy

Control group

Participants will receive none additional treatment after hysteroscopic polypectomy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Levonorgestrel Intrauterine System (LNG-IUS)

Participants in the intervention group will receive Mirena placement after hysteroscopic polypectomy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No