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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-1-2112 | Other Grant/Funding Number | The capital health research and development of special | |
| zylx201406 | Other Grant/Funding Number | Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support |
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To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dried biological amnion graft | Experimental | patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
|
| Foley catheter balloon only | Sham Comparator | patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dried biological amnion graft | Procedure | Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| second diagnostic hysteroscopy | postoperation three to four months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Xin, MD | Contact | 13681401510 | wx_0327@126.com | |
| Gan Lu, MD | Contact | 13552320665 | gl19880508@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Duan Hua, Ph.D | Beijing Obstetrics and Gynecology Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital，Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17100817 | Result | Amer MI, Abd-El-Maeboud KH. Amnion graft following hysteroscopic lysis of intrauterine adhesions. J Obstet Gynaecol Res. 2006 Dec;32(6):559-66. doi: 10.1111/j.1447-0756.2006.00454.x. | |
| 28170094 | Derived | Gan L, Duan H, Sun FQ, Xu Q, Tang YQ, Wang S. Efficacy of freeze-dried amnion graft following hysteroscopic adhesiolysis of severe intrauterine adhesions. Int J Gynaecol Obstet. 2017 May;137(2):116-122. doi: 10.1002/ijgo.12112. Epub 2017 Mar 1. |
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| Foley balloon | Device | Device: Foley balloon Uterine application of Foley balloon |
|
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| estradiol valerate tablets+dydrogesterone Tablets | Drug | oral estradiol valerate tablets+dydrogesterone Tablets |
|
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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 |
| D000091662 | Genital Diseases |
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