Status:

UNKNOWN

The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome

Lead Sponsor:

Beijing Obstetrics and Gynecology Hospital

Conditions:

Intrauterine Adhesion

Eligibility:

FEMALE

20-40 years

Phase:

NA

Brief Summary

Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the trea...

Detailed Description

The Foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. Several investigators demonstrated its favorable effect in ...

Eligibility Criteria

Inclusion

  • age 20-40 years;
  • Moderate to severe intrauterine adhesion (AFS score ≥5);
  • complains of menstruation disorder and reproductive dysfunction
  • Agreement to have second-look hysteroscopy
  • informed consent

Exclusion

  • ovarian failure
  • patients who did not proceed to second-look hysteroscopy within the specified time frame
  • Contraindication of hormone

Key Trial Info

Start Date :

October 23 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 20 2018

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT03330873

Start Date

October 23 2017

End Date

October 20 2018

Last Update

November 6 2017

Active Locations (1)

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Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, Beijing Municipality, China, 100006