ClinicalTrials.gg
Not yet recruitingNCT06620939Updated Oct 4, 2024

The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence

An interventional study of Levonorgestrel Intrauterine System (LNG-IUS) in Endometrial Polyp, sponsored by Zhang Jian. Not yet recruiting. Open to female participants aged 20 Years to 48 Years. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by Zhang Jian · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
558
Allocation
Randomized
Ages
20 Years to 48 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Endometrial Polyp

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Keywords

  • Endometrial polyp
  • Levonorgestrel intrauterine system
03

In context

Polyps

312 studies on the registry are indexed under Polyps; 60 are open to participants now.

This study's planned enrollment of 558 is above the median of 150 across 204 interventional studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

This is the only study on the registry with Zhang Jian as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 48 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  1. (1) 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) , 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
558 participants (estimated)

Study arms

  • Experimental
    LNG-IUS group

    Participants will receive Mirena placement after hysteroscopic polypectomy

    Drug: Levonorgestrel Intrauterine System (LNG-IUS)

  • No intervention
    Control group

    Participants will receive none additional treatment after hysteroscopic polypectomy.

Interventions

  • DrugLevonorgestrel Intrauterine System (LNG-IUS)

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

06

What researchers measure

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

    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.

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06620939
Lead sponsor
Zhang Jian
Collaborators
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, Shanghai
Responsible party
Zhang Jian (Principal Investigator, International Peace Maternity and Child Health Hospital) — Sponsor-investigator
First posted
Oct 1, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 4, 2024

Study contacts

Jian Zhang
Contact
zhangjian_sjtu@126.com
86+18017316017
Li Yan
Contact
yanli7720@163.com
86+18112137720
Jian Zhang
principal investigator · International Peace Maternity and Child Health Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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