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

Intrauterine Adhesions Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02404454
• Other study ID #: MulticentricMetroplasty
• Status: Not yet recruiting
• Phase: N/A
• First received: March 26, 2015
• Last updated: March 8, 2016
• Start date: June 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2016
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intrauterine Adhesions
• Septate Uterus
• Tissue Adhesions

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Cagliari	Azienda Sanitaria Locale di Cagliari, Azienda Sanitaria Locale di Olbia, Azienda Sanitaria Locale di Oristano, Università degli Studi di Sassari

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Formation of intrauterine adhesions		baseline (operative isteroscopy and three months	No