Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyaluronic Acid Gel
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|ClinicalTrials.gov Identifier: NCT02404454|
Recruitment Status : Unknown
Verified March 2016 by Stefano Angioni, University of Cagliari.
Recruitment status was: Not yet recruiting
First Posted : March 31, 2015
Last Update Posted : March 9, 2016
The septate uterus is the most common structural uterine anomaly. It results from failure of the partition between the two fused Müllerian ducts to resorb;it is associated with the highest incidence of reproductive failure and with first- and second-trimester pregnancy loss and infertility.
Hysteroscopic division of the uterine septum is performed using microscissors, electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome after hysteroscopic metroplasty.
Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine adhesions, through second look office hysteroscopy after three months.
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Adhesions Septate Uterus||Procedure: Hysteroscopic metroplasty Device: Autocross-linked acid hyaluronic gel Procedure: Office second look hysteroscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||March 2017|
Experimental: hysteroscopic metroplasty
women undergoing hysteroscopic metroplasty for uterine septum resection
Procedure: Hysteroscopic metroplasty
Device: Autocross-linked acid hyaluronic gel
Patients received adhesion barrier with 5 ml of autocross-linked acid hyaluronic gel
Procedure: Office second look hysteroscopy
Second-look hysteroscopy after three months
- Change in Formation of intrauterine adhesions [ Time Frame: baseline (operative isteroscopy and three months ]