Clinical trial NCT02220621: Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion
Official title: A Prospective, Multi-center, Randomized, Controlled Clinical Study on Self-crosslinked Sodium Hyaluronate Gel for Prevention of Intrauterine Adhesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: Intrauterine adhesion
crosslinked hyaluronan gel
hysteroscopy
clinical trial
Lead sponsor: BioRegen Biomedical (CHangzhou) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: the percentage of patients free from IUA
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Effective rate
timeFrame: three months after surgery
measure: Total AFS score
timeFrame: 3 months
measure: The score for each subcategory of AFS scoring system
timeFrame: 3 months
measure: The safety
timeFrame: 3 months
Other outcomes:
measure: Safety
timeFrame: 3 months
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changshu
country: China
facility: The People's Hospital of Hunan Province
state: Hunan
city: Chenzhou
country: China
facility: The People's Hospital of Chenzhou City,
state: Hunan
Study officials:
References:
citation: 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.