The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence

Zhang Jian

Status: Not yet enrolling

Conditions: Endometrial Polyp

Treatments: Drug: Levonorgestrel Intrauterine System (LNG-IUS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06620939

IIT-2024-19

Details and patient eligibility

About

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.

Enrollment: 558 estimated patients

Sex: Female

Ages: 20 to 48 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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558 participants in 2 patient groups

LNG-IUS group

Experimental group

Description:

Participants will receive Mirena placement after hysteroscopic polypectomy

Treatment:

Drug: Levonorgestrel Intrauterine System (LNG-IUS)

Control group

No Intervention group

Description:

Participants will receive none additional treatment after hysteroscopic polypectomy.