Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02220621
• Date of registration: 18/08/2014
• Prospective Registration: No
• Primary sponsor: Xiaozheng Shu
• Public title: Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion
• Scientific title: A Prospective, Multi-center, Randomized, Controlled Clinical Study on Self-crosslinked Sodium Hyaluronate Gel for Prevention of Intrauterine Adhesion
• Date of first enrolment: October 2011
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02220621
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

China

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Intrauterine Adhesion

Intervention(s)

Device: Foleys balloon catheter

Device: Crosslinked hyaluronic acid gel

Primary Outcome(s)

the percentage of patients free from IUA [Time Frame: 3 months after surgery]

Secondary Outcome(s)

The safety [Time Frame: 3 months]

Total AFS score [Time Frame: 3 months]

Effective rate [Time Frame: three months after surgery]

The score for each subcategory of AFS scoring system [Time Frame: 3 months]

Secondary ID(s)

FNL-2011-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors