Endometrial Polyp
Conditions
Keywords
Endometrial polyp, Levonorgestrel intrauterine system
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.
Interventions
Participants in the intervention group will receive Mirena placement after hysteroscopic polypectomy
Sponsors
Nanjing Maternity and Child Health Care Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
RenJi Hospital
Zhang Jian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Statistician
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 48 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endometrial polyps recurrence rate | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects and complications | 2 years | — |
| Visual Analogue Scale (VAS) score for chronic pelvic pain | 2 years | 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. |
Contacts
Primary ContactJian Zhang
Backup ContactLi Yan
Outcome results
None listed