NCT05360186

New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT

The Efficacy and Safety of a New Cross-linked Hyaluronan Gel to Prevent Adhesion After Ultrasound-guided Manual Vacuum Aspiration (USG-MVA): A Prospective Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester miscarriage. * To study the severity and extent of the IUA as assessed by the AFS and ESGE adhesion score in both groups of patients. * To examine the rate of complications or side effects with the NCH gel. * To assess the subsequent menstrual history and reproductive outcome in both groups of patients.

Detailed description

There is limited data to evaluate the incidence of IUA after using this NCH gel in patients undergoing surgical evacuation via USG-MVA for the treatment of first-trimester miscarriage. Previous RCT showed a significant reduction in IUA with the use of NCH gel, with IUA detected in only 9.5% of patients with NCH gel applied compared to 24.1% in the control group. However, the group did not involve patients undergoing surgical evacuation by USG-MVA. Therefore, the objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment of first-trimester miscarriage.

Conditions

• First Trimester Abortion
• Surgical Abortion
• Miscarriage With Afibrinogenemia

Interventions

Type	Name	Description
DEVICE	MateRegen® gel (BioRegen)	Modification of Hyaluronic acid structure to 3-dimensional self-cross-linked network structure enables all-dimensional coverage of tissue surface to enhance better healing process. Self-cross-linked HA hydrogels can maintain the biocompatibility and biodegradability that characterize the unmodified material. Moreover, high dynamic viscosity enables continuous indwelling in the uterine cavity. The gel could provide precise regulation, and degradation and absorption time prolonged to 7-14 days post operatively, which completely cover key postoperative healing period (5-7 days), at the highest time of intrauterine adhesion formation.

Timeline

• Start date: 2022-06-14
• Primary completion: 2026-05-14
• Completion: 2026-05-15
• First posted: 2022-05-04
• Last updated: 2025-08-13

Locations

1 site across 1 country: Hong Kong