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Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion

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ClinicalTrials.gov Identifier: NCT02220621
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaozheng Shu, BioRegen Biomedical (CHangzhou) Co., Ltd

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Device: Crosslinked hyaluronic acid gel Device: Foleys balloon catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective, Multi-center, Randomized, Controlled Clinical Study on Self-crosslinked Sodium Hyaluronate Gel for Prevention of Intrauterine Adhesion
Study Start Date : October 2011
Actual Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Effective rate [ Time Frame: three months after surgery ]
  2. Total AFS score [ Time Frame: 3 months ]
  3. The score for each subcategory of AFS scoring system [ Time Frame: 3 months ]
  4. The safety [ Time Frame: 3 months ]
    Evaluated based on the number of patients shown complications and incidence rate for severe adverse events


Other Outcome Measures:
  1. Safety [ Time Frame: 3 months ]
    Severe adverse event (SAE): cause prolonged hospitalization and disability to the patient.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220621


Locations
China, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
The People's Hospital of Hunan Province
Changshu, Hunan, China, 410005
The People's Hospital of Chenzhou City,
Chenzhou, Hunan, China, 423000
Sponsors and Collaborators
Xiaozheng Shu

Publications:
Responsible Party: Xiaozheng Shu, CEO, BioRegen Biomedical (CHangzhou) Co., Ltd
ClinicalTrials.gov Identifier: NCT02220621     History of Changes
Other Study ID Numbers: FNL-2011-03
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by Xiaozheng Shu, BioRegen Biomedical (CHangzhou) Co., Ltd:
Intrauterine adhesion
crosslinked hyaluronan gel
hysteroscopy
clinical trial

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents