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

Primary Purpose

Intrauterine Adhesions, Septate Uterus

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Hysteroscopic metroplasty

Autocross-linked acid hyaluronic gel

Office second look hysteroscopy

About this trial

This is an interventional prevention trial for Intrauterine Adhesions

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hysteroscopic metroplasty

Arm Description

women undergoing hysteroscopic metroplasty for uterine septum resection

Outcomes

Primary Outcome Measures

Change in Formation of intrauterine adhesions

Secondary Outcome Measures

Full Information

NCT ID

NCT02404454

First Posted

March 26, 2015

Last Updated

March 8, 2016

Sponsor

University of Cagliari

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02404454

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cagliari

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intrauterine Adhesions, Septate Uterus

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

hysteroscopic metroplasty

Arm Type

Experimental

Arm Description

women undergoing hysteroscopic metroplasty for uterine septum resection

Intervention Type

Procedure

Intervention Name(s)

Hysteroscopic metroplasty

Intervention Type

Device

Intervention Name(s)

Autocross-linked acid hyaluronic gel

Intervention Description

Patients received adhesion barrier with 5 ml of autocross-linked acid hyaluronic gel

Intervention Type

Procedure

Intervention Name(s)

Office second look hysteroscopy

Intervention Description

Second-look hysteroscopy after three months

Primary Outcome Measure Information:

Title

Change in Formation of intrauterine adhesions

Time Frame

baseline (operative isteroscopy and three months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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)

12. IPD Sharing Statement

Learn more about this trial

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

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