NCT06620939

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Dec 2024

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Dec 2024Dec 2028

First Submitted

Initial submission to the registry

September 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

October 4, 2024

Status Verified

August 1, 2024

Enrollment Period

4.1 years

First QC Date

September 27, 2024

Last Update Submit

October 2, 2024

Conditions

Endometrial Polyp

Keywords

Endometrial polypLevonorgestrel intrauterine system

Outcome Measures

Primary Outcomes (1)

  • Endometrial polyps recurrence rate

    2 years

Secondary Outcomes (2)

  • Side effects and complications

    2 years

  • Visual Analogue Scale (VAS) score for chronic pelvic pain

    2 years

Study Arms (2)

LNG-IUS group

EXPERIMENTAL

Participants will receive Mirena placement after hysteroscopic polypectomy

Drug: Levonorgestrel Intrauterine System (LNG-IUS)

Control group

NO INTERVENTION

Participants will receive none additional treatment after hysteroscopic polypectomy.

Interventions

Levonorgestrel Intrauterine System (LNG-IUS)DRUG

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

LNG-IUS group

Eligibility Criteria

Age20 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • （1）Contraindications for a hysteroscopic polypectomy or LNG-IUS or not willing to receive this type surgery；
  • （2）Women who have a positive pregnancy test；
  • （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）Postoperative pathology confirmed non-endometrial polyps；
  • （5）Postoperative pathology confirmed endometrial proliferative diseases which need hormone drug therapy after surgery；
  • （6）Treatment with hormonal three months before surgery；
  • （7）The uterine cavity is more than 10 cm deep；
  • （8）Women with severe diseases；
  • （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）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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jian Zhang

    International Peace Maternity and Child Health Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhang

CONTACT

86+18017316017zhangjian_sjtu@126.com

Li Yan

CONTACT

86+18112137720yanli7720@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Statistician
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2024

First Posted

October 1, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

October 4, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share