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The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence

ConditionEndometrial Polyp
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-48
SponsorZhang Jian

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

（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；

Disqualifiers

（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；

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levonorgestrel Intrauterine System (LNG-IUS)

    Drug

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

Treatment groups

558 Participants
are divided into 2 treatment groups
Group A: LNG-IUS groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Endometrial polyps recurrence rate

Time frame
2 years

Secondary outcomes

1

Side effects and complications

Time frame
2 years
2

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.

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhang Jian

Lead sponsor

International Peace Maternity and Child Health Hospital

Sponsor institution

Nanjing Maternity and Child Health Care Hospital

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School

Collaborator

RenJi Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: