Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Procedure: dried biological amnion graft
* Device: disposable balloon uterine stent
* Drug: estradiol valerate tablets
* Drug: dydrogesterone Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20-45 years. previously diagnostic hysteroscopy confirmed adhesion score ≧5， according to the American Fertility Society (AFS). complains of menstruation disorder and reproductive dysfunction. informed consent. Exclusion Criteria: premature menopause, presence of other intrauterine lesions (e.g. polyps, myoma, septa), and presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases), adhesions limited to the lower uterine cavity or the cervical canal.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dried biological amnion graft<br>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. | Procedure: dried biological amnion graft<br>* dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .<br>* Other names: uterine application of amnion membrance;Device: disposable balloon uterine stent<br>* 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.<br>Drug: estradiol valerate tablets<br>* oral estradiol valerate tablets, which can promote endometrial growth after operation.<br>* Other names: Progynova;Drug: dydrogesterone Tablets<br>* oral dydrogesterone Tablets<br>* Other names: Duphaston;|
| Sham Comparator: disposable balloon uterine stent only<br>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. | Device: disposable balloon uterine stent<br>* 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.<br>Drug: estradiol valerate tablets<br>* oral estradiol valerate tablets, which can promote endometrial growth after operation.<br>* Other names: Progynova;Drug: dydrogesterone Tablets<br>* oral dydrogesterone Tablets<br>* Other names: Duphaston;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy | the number of biochemical pregnancy or clinical pregnancy | postoperation one year | 
| Menstruation Pattern | Amenorrhoea, hypomenorrhea, normal menstrual volume | postoperation three months | 
| adhesion reformation | Adhesion is seen under direct vision by hysteroscopy | postoperation three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asherman syndrome, uterine stent, hysteroscopy