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

Not Applicable

• Conditions: Septate Uterus; Intrauterine Adhesions
• Interventions: Procedure: Hysteroscopic metroplasty; Device: Autocross-linked acid hyaluronic gel; Procedure: Office second look hysteroscopy

• Registration Number: NCT02404454
• Lead Sponsor: University of Cagliari

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09
• Study Start: 2016-06
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• uterine septum
• history of ≥1 miscarriage or infertility;
• desire to have children in the future

Exclusion Criteria

• pregnancy;
• menopause;
• precancerous state or malignancy of the reproductive organs;
• benign lesions in the myometrium of the uterine fundus (myomas or adenomyosis)
• lesions distorting the uterine cavity (submucosal myomas or intrauterine adhesions) on ultrasonography;
• withdrawal of patient consent;
• rare complex uterine congenital anomalies without an ASRM classification such as uterine septum with double cervix ;
• presence of external intercornual cleft;
• incomplete (internal fundal indentation 10 mm) or non-standardized septum resection (internal fundal indentation ,10 mm and uterine myometrial thickness .10 mm at the fundus), confirmed intraoperatively
• excessive fundal incision (uterine myometrial thickness ,6 mm at the fundus confirmed intraoperatively)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hysteroscopic metroplasty	Hysteroscopic metroplasty	women undergoing hysteroscopic metroplasty for uterine septum resection
hysteroscopic metroplasty	Autocross-linked acid hyaluronic gel	women undergoing hysteroscopic metroplasty for uterine septum resection
hysteroscopic metroplasty	Office second look hysteroscopy	women undergoing hysteroscopic metroplasty for uterine septum resection

Primary Outcome Measures

Name	Time	Method
Change in Formation of intrauterine adhesions	baseline (operative isteroscopy and three months