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Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

NCT04972032 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2021-09-17

No results posted yet for this study

Summary

This is a prospective, randomized, single-blinded,multi-center trial to compare the efficacy of an Estrogen-intrauterine stent system with foley balloon combined with intrauterine cross-linked sodium hyaluronate gel in the prevention of intrauterine adhsion recurrence after hysteroscopic adhesiolysis.

Conditions

  • Intrauterine Adhesion

Interventions

DEVICE

Estrogen Intrauterine Stent System

A Estrogen Intrauterine Stent System（E-IUS）will be introduced post-operatively. The E-IUS will be removed 60 days after surgery with continuous dydrogesterone administration for 5 days at 20 mg/d, and routine management.

DEVICE

Foley balloon combined with self-cross-link sodium hyaluronate gel

Foley balloon combined with self-crosslinking sodium hyaluronate gel will be introduced post-operatively，2 cycles of estrogen-progestin sequential therapy comprised of continuous estrogen and progestin added in the second half of the cycle or continuous estradiol valerate for 60 days, followed by dydrogesterone for 10 days

Sponsors & Collaborators

  • Limin Feng

    lead OTHER

Principal Investigators

  • Limin Feng · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2024-03-31
Completion
2025-03-31

Countries

  • China

Study Locations

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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 NCT04972032 on ClinicalTrials.gov