Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion

Intrauterine Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220621
• Other study ID #: FNL-2011-03
• Status: Completed
• Phase: N/A
• First received: August 18, 2014
• Last updated: August 18, 2014
• Start date: October 2011

Study information

• Verified date: August 2014
• Source: BioRegen Biomedical (CHangzhou) Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chinese Food and Drug Administration China:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Device:
• Crosslinked hyaluronic acid gel
After hysteroscopic adhesiolysis, MateRegen Gel IU is applied into the uterine cavity together with a Foley balloon catheter.
• Foleys balloon catheter
After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline.

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	The People's Hospital of Hunan Province	Changshu	Hunan
China	The People's Hospital of Chenzhou City,	Chenzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiaozheng Shu

Country where clinical trial is conducted

China, 

References & Publications (1)

Acunzo G, Guida M, Pellicano M, Tommaselli GA, Di Spiezio Sardo A, Bifulco G, Cirillo D, Taylor A, Nappi C. Effectiveness of auto-cross-linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis: a prospective, randomized, controlled study. Hum Reprod. 2003 Sep;18(9):1918-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Severe adverse event (SAE): cause prolonged hospitalization and disability to the patient.	3 months	Yes
Primary	the percentage of patients free from IUA	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	No
Secondary	Effective rate		three months after surgery	No
Secondary	Total AFS score		3 months	No
Secondary	The score for each subcategory of AFS scoring system		3 months	No
Secondary	The safety	Evaluated based on the number of patients shown complications and incidence rate for severe adverse events	3 months	Yes