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

NCT02404454 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-03-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Università degli Studi di Sassari

    collaborator OTHER

  • Azienda Sanitaria Locale di Cagliari

    collaborator OTHER

  • Azienda Sanitaria Locale di Olbia

    collaborator OTHER

  • Azienda Sanitaria Locale di Oristano

    collaborator OTHER

  • University of Cagliari

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-12-31
Completion
2017-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02404454 on ClinicalTrials.gov