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Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

NCT06478992 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2024-06-27

No results posted yet for this study

Summary

The purpose of this study was to evaluate the efficacy and safety of hysteroscopic Mirena fixation in patients with adenomyosis with enlarged uterus, compared with simple Mirena placement under hysteroscopy. Whether the curative effect is not inferior to and reduces the incidence of Mirena expulsion.

Conditions

  • Adenomyosis
  • Hysteroscopy

Interventions

PROCEDURE

A:hysteroscopic suture fixation of Mirena

A(the thickness of the thickest uterine myometrium ≥30mm ):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.

PROCEDURE

A: simple Mirena placement under hysteroscopy

A(the thickness of the thickest uterine myometrium ≥30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.

PROCEDURE

B: hysteroscopic suture fixation of Mirena

B(the thickness of the thickest uterine myometrium\<30mm):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.

PROCEDURE

B：simple Mirena placement under hysteroscopy

B(the thickness of the thickest uterine myometrium\<30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-12-30
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478992 on ClinicalTrials.gov