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

First Trimester Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05360186
• Other study ID #: 2021.702-T
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: May 15, 2026

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Elaine NG
• Phone: 35052745
• Email: elaineng[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 15, 2026
• Est. primary completion date: May 14, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Afibrinogenemia
• First Trimester Abortion
• Surgical Abortion
• Tissue Adhesions

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Health and Medical Research Fund

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of IUA	To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.	8-12 weeks after MVA
Secondary	Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score	To study the severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score in both groups of patients.; The American Fertility Society's (AFS) classification of intrauterine adhesions: Stage I (mild) with score 1-4, Stage II (moderate) with score 5-8, Stage III (severe) with score 9-12	8-12 weeks after MVA
Secondary	Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score	To study the severity and extent of the intrauterine adhesions as assessed by the European Society of Gynaecological Endoscopy (ESGE) adhesion score in both groups of patients. It includes grades I and II as mild adhesion, grade III as moderate adhesion, grades IV and V as severe adhesion	8-12 weeks after MVA
Secondary	Complications or side effects with the NCH gel.	To examine the rate of complications or side effects with the NCH gel.	8-12 weeks after MVA
Secondary	Subsequent menstrual frequency	To assess the subsequent menstrual frequency in both groups of patients. Frequency - average 28 days <24 days Frequent, >38 days Infrequent Frequency - average 28 days <24 days Frequent, >38 days Infrequent	8-12 weeks after MVA
Secondary	Subsequent reproductive outcome	To assess the rate of pregnancy in both groups of patients	8-12 weeks after MVA