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

NCT ID: NCT05360186

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2026-05-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention group (Group A): NCH gel after USG-MVA

In the intervention group (Group A), a 15 cm sterile delivery cannula will be inserted through the internal os and a syringe of NCH gel (5ml) will be applied to the uterine cavity after cleansing the cervix with an antiseptic solution.

Group Type: EXPERIMENTAL

MateRegen® gel (BioRegen)

Intervention Type: DEVICE

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.

Controlled group (Group B): No NCH gel after USG-MVA

In the control group (Group B), as the patient is conscious during the procedure, an empty 5ml syringe will be inserted into the internal os and held for 1 minute as a sham procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women 18 years old or above
• No previous history of IUA/ Asherman's syndrome
• No previous surgical history of EVA or dilatation or curettage or surgical termination of pregnancy or caesarean section
• No previous history of therapeutic hysteroscopic surgeries
• Voluntary informed consent and understanding of study

Exclusion Criteria

• previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis)
• suspicion of molar pregnancy
• genital tract malformation
• suspicion of active infection or genital tract malignancy or genital tuberculosis
• abnormal blood coagulation
• inability to tolerate pelvic examination known
• suspected intolerance of hypersensitivity to NCH gel or its derivatives
• patient refusal

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Health and Medical Research Fund

OTHER_GOV

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Chung Pui Wah Jacqueline

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Elaine NG

Role: CONTACT

elaineng@cuhk.edu.hk

35052745

Stacey Wong, Bsc

Role: CONTACT

staceywong@cuhk.edu.hk

35051764

Facility Contacts

PUI WAH JACQUELINE CHUNG, MBBS

Role: primary

jacquelinechung@cuhk.edu.hk

+852 35051537

Stacey Wong, Bsc

Role: backup

staceywong@cuhk.edu.hk

+852-35051764

Other Identifiers

2021.702-T

Identifier Type: -

Identifier Source: org_study_id