NCT06478992

Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

A Multicenter Randomized Controlled Trial of Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.

Conditions

• Adenomyosis
• Hysteroscopy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-30
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2024-06-27
• Last updated: 2024-06-27