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NCT Number: NCT06620939

The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence

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.

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Key information

Conditions

Endometrial Polyp

Age range

20 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • （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；
  • （5）Signed informed consent.

Exclusion criteria

  • （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；
  • （5）Postoperative pathology confirmed endometrial proliferative diseases which need hormone drug therapy after surgery；
  • （6）Treatment with hormonal three months before surgery；
  • （7）The uterine cavity is more than 10 cm deep；
  • （8）Women with severe diseases；
  • （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）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.

Treatment and study plan

Levonorgestrel Intrauterine System (LNG-IUS)

Drug

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

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Zhang

CONTACT

[email protected]

86+18017316017

Li Yan

CONTACT

[email protected]

86+18112137720

Sponsors and collaborators

Lead sponsor

Zhang Jian

Other

Collaborators

  • Nanjing Maternity and Child Health Care Hospital
  • RenJi Hospital
  • Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence After Hysteroscopic Polypectomy: Protocol of a Multi-center Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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