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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. Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been reported that dried biological amnion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Disposable balloon uterine stent,which is an innovative intrauterine balloon,is specially designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and amniotic products combine estrogen therapy improve clinical outcomes? Therefore, this study was conducted.
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uterine cavity barrier only | Experimental | patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis. |
|
| hormone | Experimental | patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ amnion membrane+hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 compare to Foley catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adhesion information | Intrauterine adhesions under hysteroscopy | Within the first 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Menstruation Pattern | menstrual volume which was assessed by pictorial blood loss assessment chart | Within the first 3 months after surgery |
| The change of AFS score | he American Fertility Society ( AFS ) scoring system (1988 version). Scores of 1-4, 5-8, and 9-12 were mild, moderate, and severe adhesions, respectively. |
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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, MD | Contact | 15201556908 | wangsha1020@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Duan Hua, MD | 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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| dried biological amnion graft | Procedure | Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis. Other Name: Human amnion membrane |
|
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| estradiol valerate tablets+dydrogesterone tablets | Drug | oral estradiol valerate tablets+dydrogesterone tablets |
|
|
| Within the first 3 months after surgery |
| 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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