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Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon and amniotic products can improve clinical outcomes? Therefore, this study was conducted.
The diaposable balloon uterine(a special intrauterine balloon) is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery. Another group, the diaposable balloon uterin and dried biological amnion will be inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery.Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
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 | dried biological amnion graft patients, who are with IUA, treated by uterine application of dried biological amnion graft + disposable balloon uterine stent + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
|
| disposable balloon uterine stent only | Sham Comparator | disposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent only + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dried biological amnion graft | Procedure | dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent . |
|
| Measure | Description | Time Frame |
|---|---|---|
| second diagnostic hysteroscopy | American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively | postoperation three months |
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy | the number of biochemical pregnancy or clinical pregnancy | postoperation one year |
| Menstruation Pattern | Amenorrhoea, hypomenorrhea, normal menstrual volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhu Ru, MD | Contact | 13966636438 | zhuru19790202@163.com | |
| Wang Sha, PhD | Contact | 15201556908 | wangsha1020@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Duan Hua, PhD | Beijing Obstetrics and Gynecology Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital, Capital Medical University | Recruiting | Beijing | China |
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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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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| disposable balloon uterine stent | Device | the disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus. |
|
| estradiol valerate tablets | Drug | oral estradiol valerate tablets, which can promote endometrial growth after operation. |
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| dydrogesterone Tablets | Drug | oral dydrogesterone Tablets |
|
|
| postoperation three months |
| adhesion reformation | Adhesion is seen under direct vision by hysteroscopy | postoperation three months |
| D000091662 | Genital Diseases |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |