Endometrial PolypNCT06620939
The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence
A study testing Levonorgestrel Intrauterine System (LNG-IUS) in people with Endometrial Polyp, run by Zhang Jian.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 48 years, women only
- Conditions the study is for
- Endometrial Polyp
- What is being tested?
- Levonorgestrel Intrauterine System (LNG-IUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- （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.
Who cannot join
- （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；
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- （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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence After Hysteroscopic Polypectomy: Protocol of a Multi-center Randomised Controlled Trial
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.
- Conditions
- Endometrial Polyp
- Being tested
- Levonorgestrel Intrauterine System (LNG-IUS)
- Keywords
- Endometrial polyp, Levonorgestrel intrauterine system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel Intrauterine System (LNG-IUS)Drug
Participants in the intervention group will receive Mirena placement after hysteroscopic polypectomy
| Study group | Role | What they receive |
|---|---|---|
| LNG-IUS group | Experimental | Participants will receive Mirena placement after hysteroscopic polypectomy Receives: Drug: Levonorgestrel Intrauterine System (LNG-IUS) |
| Control group | No intervention | Participants will receive none additional treatment after hysteroscopic polypectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial polyps recurrence rate
Measured: 2 years
Secondary outcomes (2)
Side effects and complications
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang Jian
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Zhang Jian, International Peace Maternity and Child Health Hospital
- Investigators
- Jian Zhang, Principal investigator, International Peace Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620939
- Sponsor's protocol ID
- IIT-2024-19
- Status last verified
- Aug 2024
- First submitted
- 27 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Levonorgestrel Intrauterine System in Preventing Endometrial Polyps Recurrence After Hysteroscopic Polypectomy: Protocol of a Multi-center Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06620939
- Acronym / sponsor ID
- IIT-2024-19
- Conditions
- Endometrial Polyp
- Keywords
- Endometrial polyp, Levonorgestrel intrauterine system
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- Zhang JianUniversity, hospital or other
- 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
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNG-IUS group | Experimental | Drug: Levonorgestrel Intrauterine System (LNG-IUS)Participants will receive Mirena placement after hysteroscopic polypectomy |
| Control group | No intervention | –Participants will receive none additional treatment after hysteroscopic polypectomy. |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- （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.
Key exclusion criteria (10 listed)
- （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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel Intrauterine System (LNG-IUS)Participants in the intervention group will receive Mirena placement after hysteroscopic polypectomy | Drug | LNG-IUS group |
Primary outcome
Endometrial polyps recurrence rate
Time frame: 2 years
2 secondary outcomes
Side effects and complications
Time frame: 2 years
Visual Analogue Scale (VAS) score for chronic pelvic pain
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Zhang principal investigator
International Peace Maternity and Child Health Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgestrel Intrauterine System (LNG-IUS) in people with Endometrial Polyp, run by Zhang Jian.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang (86+18017316017, zhangjian_sjtu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial polyps recurrence rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.