Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion

NCT ID: NCT02220621

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31

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.

Conditions

Intrauterine Adhesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Crosslinked hyaluronic acid gel

Intervention Type: DEVICE

After hysteroscopic adhesiolysis, MateRegen Gel IU is applied into the uterine cavity together with a Foley balloon catheter.

Foleys balloon catheter

Intervention Type: DEVICE

After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline.

Control

After hysteroscopic adhesiolysis, a Foleys balloon catheter is inserted into the unterine cavity.

Group Type: ACTIVE_COMPARATOR

Foleys balloon catheter

Intervention Type: DEVICE

After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline.

Interventions

Crosslinked hyaluronic acid gel

After hysteroscopic adhesiolysis, MateRegen Gel IU is applied into the uterine cavity together with a Foley balloon catheter.

Intervention Type: DEVICE

Foleys balloon catheter

After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline.

Intervention Type: DEVICE

Other Intervention Names

MateRegen Gel IU.

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xiaozheng Shu

INDUSTRY

Sponsor Role: lead

Responsible Party

Xiaozheng Shu

CEO

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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, China

Countries

China

References

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. doi: 10.1093/humrep/deg368.

Reference Type: BACKGROUND

PMID: 12923149 (View on PubMed)

Other Identifiers

FNL-2011-03

Identifier Type: -

Identifier Source: org_study_id