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

University of Cagliari

Status: Unknown

Conditions: Intrauterine Adhesions; Septate Uterus

Treatments: Procedure: Hysteroscopic metroplasty; Device: Autocross-linked acid hyaluronic gel; Procedure: Office second look hysteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02404454

MulticentricMetroplasty

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

hysteroscopic metroplasty

Experimental group

Description:

women undergoing hysteroscopic metroplasty for uterine septum resection

Treatment:

Procedure: Office second look hysteroscopy

Device: Autocross-linked acid hyaluronic gel

Procedure: Hysteroscopic metroplasty