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
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
Treatments tested in this trial
- Levonorgestrel Intrauterine System (LNG-IUS)
Treatment groups
558 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
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