Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion

August 18, 2014 updated by: Xiaozheng Shu

A Prospective, Multi-center, Randomized, Controlled Clinical Study on Self-crosslinked Sodium Hyaluronate Gel for Prevention of Intrauterine Adhesion

Intrauterine adhesion (IUA) is the adhesion of intrauterine tissues due to the exposure of myometrial tissues caused by the endometrial basal injury. IUA is clinically manifested as symptoms such as abdominal pain, hypomenorrhea or amenorrhea, sterility and habitual abortion, which seriously affect the patients quality of life.

Preventing IUA has been tried using different methods such as barrier or stent in order to separate the opposing endometrium during the tissue healing processes. Although some successes have been reported there are still some challenges need to be dealt with.

One of the barrier materials for preventing IUA is made of hyaluronic acid (HA). HA is a natural ECM of human tissue with excellent biocompatibility and promotes the scar-free wound repair. The self-crosslinked esterified HA gel has demonstrated the capacity to prevent IUA in clinical studies.

A novel self-crosslinked HA gel is developed by BioRegen Biomedical（Changzhou）Co., Ltd with proprietary technologies. This product is a highly viscoelastic crosslinked gel that overcomes the shortcoming of sodium hyaluronate with high motility and too quick degradation in vivo. For this product, the results of animal experiments and various safety features have been designed and tested conforming to the national regulations and standards. In order to launch this product to the market, this prospective, randomized and controlled clinical trial is designed and will be performed to verify its safety/efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • The Third Xiangya Hospital of Central South University
      • Changshu, Hunan, China, 410005
        • The People's Hospital of Hunan Province
      • Chenzhou, Hunan, China, 423000
        • The People's Hospital of Chenzhou City,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients who are 20-40 years old who is diagnosed as intrauterine adhesion, and did not receive adhesiolysis surgery.
  • Patients who signed the informed consent form (ICF) and agreed to take contraceptive measures within 3 months after the surgery.
  • Physical examination and routine laboratory tests demonstrated no systemic diseases.
  • According to the AFS scoring system on the IUA (1988) only those patients with moderate to severe IUA (i.e. total AFS score larger than 4 points) were enrolled in this clinical trial.

Exclusion Criteria:

  • Patients who is allergic to hyaluronan or its derivatives.
  • Patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia.
  • Patients with malformation of reproductive organs.
  • Patients who may not take effective contraceptive measures within 3 months after the surgery. Patients who were suffering severe systemic diseases such as coagulative disorders, cardiovascular diseases and long-term alcoholism and drug abuse were also excluded from this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
After the hysteroscopic adhesiolysis, crosslinked hyaluronic acid gel is applied into the uterine cavity, then a Foleys balloon catheter is inserted into the uterine cavity.
Device: Crosslinked hyaluronic acid gel
After hysteroscopic adhesiolysis, MateRegen Gel IU is applied into the uterine cavity together with a Foley balloon catheter.
Other Names:
  • MateRegen Gel IU.
Device: Foleys balloon catheter
After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline.
Active Comparator: Control
After hysteroscopic adhesiolysis, a Foleys balloon catheter is inserted into the unterine cavity.
Device: Foleys balloon catheter
After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of patients free from IUA
Time Frame: 3 months after surgery
Second look hysteroscopic examinations were performed at 3 months postoperatively. The adhesion was scored at adhesiolysis surgery and at follow-up hysteroscopy according to American Fertility Society scoring system.
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective rate
Time Frame: three months after surgery
three months after surgery
Total AFS score
Time Frame: 3 months
3 months
The score for each subcategory of AFS scoring system
Time Frame: 3 months
3 months
The safety
Time Frame: 3 months
Evaluated based on the number of patients shown complications and incidence rate for severe adverse events
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 3 months
Severe adverse event (SAE): cause prolonged hospitalization and disability to the patient.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaozheng Shu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNL-2011-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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