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

March 8, 2016 updated by: Stefano Angioni, University of Cagliari

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Formation of intrauterine adhesions
Time Frame: baseline (operative isteroscopy and three months
baseline (operative isteroscopy and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Collaborators

Azienda Sanitaria Locale di Cagliari
Università degli Studi di Sassari
Azienda Sanitaria Locale di Olbia
Azienda Sanitaria Locale di Oristano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MulticentricMetroplasty

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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