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

NCT ID: NCT02404454

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-03-31

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.

Conditions

Intrauterine Adhesions; Septate Uterus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

hysteroscopic metroplasty

women undergoing hysteroscopic metroplasty for uterine septum resection

Group Type: EXPERIMENTAL

Hysteroscopic metroplasty

Intervention Type: PROCEDURE

Autocross-linked acid hyaluronic gel

Intervention Type: DEVICE

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

Office second look hysteroscopy

Intervention Type: PROCEDURE

Second-look hysteroscopy after three months

Interventions

Hysteroscopic metroplasty

Intervention Type: PROCEDURE

Autocross-linked acid hyaluronic gel

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

Intervention Type: DEVICE

Office second look hysteroscopy

Second-look hysteroscopy after three months

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Università degli Studi di Sassari

OTHER

Sponsor Role: collaborator

Azienda Sanitaria Locale di Cagliari

OTHER

Sponsor Role: collaborator

Azienda Sanitaria Locale di Olbia

OTHER

Sponsor Role: collaborator

Azienda Sanitaria Locale di Oristano

OTHER

Sponsor Role: collaborator

University of Cagliari

OTHER

Sponsor Role: lead

Responsible Party

Stefano Angioni

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MulticentricMetroplasty

Identifier Type: -

Identifier Source: org_study_id