The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence

The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence After Hysteroscopic Polypectomy: Protocol of a Multi-center Randomised Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endometrial Polyp
• Intervention / Treatment: Drug: Levonorgestrel Intrauterine System (LNG-IUS)

• Study Type: Interventional
• Enrollment (Estimated): 558
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Zhang; Phone Number: 86+18017316017; Email: zhangjian_sjtu@126.com
• Study Contact Backup: Name: Li Yan; Phone Number: 86+18112137720; Email: yanli7720@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LNG-IUS group; Participants will receive Mirena placement after hysteroscopic polypectomy	Drug: Levonorgestrel Intrauterine System (LNG-IUS); Participants in the intervention group will receive Mirena placement after hysteroscopic polypectomy
No Intervention: Control group; Participants will receive none additional treatment after hysteroscopic polypectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endometrial polyps recurrence rate	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects and complications		2 years
Visual Analogue Scale (VAS) score for chronic pelvic pain	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.	2 years

Collaborators and Investigators

• Sponsor: Zhang Jian
• Collaborators: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Nanjing Maternity and Child Health Care Hospital; Renji Hospital, Shanghai; Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
• Investigators: Principal Investigator: Jian Zhang, International Peace Maternity and Child Health Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Endometrial polyp; Levonorgestrel intrauterine system
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Disease Attributes; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Recurrence; Polyps; Uterine Neoplasms; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: IIT-2024-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No