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NCT Number: NCT05360186

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

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.

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Key information

Conditions

First Trimester Abortion Abortion, Spontaneous Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Miscarriage With Afibrinogenemia Pregnancy Complications Surgical Abortion Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MateRegen® gel (BioRegen)

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.

Primary outcomes

  1. Incidence of IUA

    Time frame: 8-12 weeks after MVA

    To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.

Secondary outcomes

  1. Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score

    Time frame: 8-12 weeks after MVA

    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

  2. Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score

    Time frame: 8-12 weeks after MVA

    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

  3. Complications or side effects with the NCH gel.

    Time frame: 8-12 weeks after MVA

    To examine the rate of complications or side effects with the NCH gel.

  4. Subsequent menstrual frequency

    Time frame: 8-12 weeks after MVA

    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

  5. Subsequent reproductive outcome

    Time frame: 8-12 weeks after MVA

    To assess the rate of pregnancy in both groups of patients

Study contacts

Contact information is provided by the study sponsor or research team.

Elaine NG

CONTACT

[email protected]

35052745

Stacey Wong, Bsc

CONTACT

[email protected]

35051764

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 4, 2022
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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