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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
Sponsor:
Collaborators:
Università degli Studi di Sassari
Azienda Sanitaria Locale di Cagliari
Azienda Sanitaria Locale di Olbia
Azienda Sanitaria Locale di Oristano
Information provided by (Responsible Party):
Stefano Angioni, University of Cagliari

Study Description
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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.


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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Formation of intrauterine adhesions [ Time Frame: baseline (operative isteroscopy and three months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Stefano Angioni, Associate Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT02404454    
Other Study ID Numbers: MulticentricMetroplasty
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents