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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Control | Active Comparator | After hysteroscopic adhesiolysis, a Foleys balloon catheter is inserted into the unterine cavity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crosslinked hyaluronic acid gel | Device | After hysteroscopic adhesiolysis, MateRegen Gel IU is applied into the uterine cavity together with a Foley balloon catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effective rate | three months after surgery | |
| Total AFS score | 3 months | |
| The score for each subcategory of AFS scoring system |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Severe adverse event (SAE): cause prolonged hospitalization and disability to the patient. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China | ||
| The People's Hospital of Hunan Province |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12923149 | Background | 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. |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| Foleys balloon catheter | Device | After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline. |
|
| 3 months |
| The safety | Evaluated based on the number of patients shown complications and incidence rate for severe adverse events | 3 months |
| Changshu |
| Hunan |
| 410005 |
| China |
| The People's Hospital of Chenzhou City, | Chenzhou | Hunan | 423000 | China |
| D000091662 | Genital Diseases |