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Trial Title:
The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence
NCT ID:
NCT06620939
Condition:
Endometrial Polyp
Conditions: Official terms:
Uterine Neoplasms
Recurrence
Polyps
Levonorgestrel
Conditions: Keywords:
Endometrial polyp
Levonorgestrel intrauterine system
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
Statistician
Intervention:
Intervention type:
Drug
Intervention name:
Levonorgestrel Intrauterine System (LNG-IUS)
Description:
Participants in the intervention group will receive Mirena placement after hysteroscopic
polypectomy
Arm group label:
LNG-IUS group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
48 Years
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Zhang Jian
Agency class:
Other
Collaborator:
Agency:
Nanjing Maternity and Child Health Care Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
Agency class:
Other
Collaborator:
Agency:
Renji Hospital, Shanghai
Agency class:
Other
Source:
International Peace Maternity and Child Health Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06620939
