NCT02404454

Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyaluronic Acid Gel

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Cagliari · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Intrauterine Adhesions
• Septate Uterus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2015-03-31
• Last updated: 2016-03-09