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

NCT05360186 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-08-13

No results posted yet for this study

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.

Conditions

  • First Trimester Abortion
  • Surgical Abortion
  • Miscarriage With Afibrinogenemia

Interventions

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.

Sponsors & Collaborators

  • Health and Medical Research Fund

    collaborator OTHER_GOV

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2026-05-14
Completion
2026-05-15

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05360186 on ClinicalTrials.gov