Clinical trial NCT06620939: The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence
Official title: The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence After Hysteroscopic Polypectomy: Protocol of a Multi-center Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometrial Polyp
Keywords: Endometrial polyp
Levonorgestrel intrauterine system
Lead sponsor: International Peace Maternity and Child Health Hospital
Sponsor class: OTHER
Collaborators: name: Nanjing Maternity and Child Health Care Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
name: Renji Hospital, Shanghai
First posted: 2024-10-01
Enrollment: 558
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Endometrial polyps recurrence rate
timeFrame: 2 years
Secondary outcomes:
measure: Side effects and complications
timeFrame: 2 years
measure: Visual Analogue Scale (VAS) score for chronic pelvic pain
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: International Peace Maternity and Child Health Hospital
name: Jian Zhang
role: PRINCIPAL_INVESTIGATOR
References: