Clinical Trial: Comparing the Efficacy of Intrauterine Balloon and Intrauterine Contraceptive Device for the Therapy of Uterine Adhesion

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis

Brief Summary: This study was taken out to compare two mechanical devices (intrauterine balloon and intrauterine contraceptive device) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.

Detailed Summary:

Intrauterine balloon and IUD are both effective in the therapy for intrauterine adhesion.

The IUD is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after two or three month later. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion.

The heart-shaped intrauterine balloon is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Sponsor: Wenzhou Medical University

Current Primary Outcome: The change of AFS score （The American Fertility Society classifications）in two menstrual cycles [ Time Frame: baseline and two months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Wenzhou Medical University

Dates:
Date Received: April 11, 2016
Date Started: June 2015
Date Completion: June 2017
Last Updated: August 10, 2016
Last Verified: August 2016