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Not yet recruiting NCT06620939

The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence

No phase Interventional Endometrial Polyp

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Levonorgestrel Intrauterine System (LNG-IUS).
Who it may be relevant to
Registry conditions: Endometrial Polyp. Basic parameters: 20 years — 48 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Levonorgestrel Intrauterine System (LNG-IUS)
    Participants in the intervention group will receive Mirena placement after hysteroscopic polypectomy

Primary outcome measures

  • Endometrial polyps recurrence rate [Time frame: 2 years]
Secondary outcome measures (2)
  • Side effects and complications [Time frame: 2 years]
  • Visual Analogue Scale (VAS) score for chronic pelvic pain [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • （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.

Exclusion criteria

  • （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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06620939 · IIT-2024-19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗