The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis

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. 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.

Detailed Description
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Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention

Official Title
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Randomized, Controlled Trial to Assess the Efficacy of Estrogen Therapy Combined With Disposable Balloon Uterine Stent and 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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* Device: disposable balloon uterine stent
* Procedure: dried biological amnion graft
* Drug: estradiol valerate tablets+dydrogesterone tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20-40 years； previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA； 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: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterine cavity barrier only<br>patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane 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 compare to Foley catheter.<br>Procedure: dried biological amnion graft<br>* Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis. Other Name: Human amnion membrane<br>* Other names: amnion membrane;|
| Experimental: hormone<br>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. | 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 compare to Foley catheter.<br>Procedure: dried biological amnion graft<br>* Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis. Other Name: Human amnion membrane<br>* Other names: amnion membrane;Drug: estradiol valerate tablets+dydrogesterone tablets<br>* oral estradiol valerate tablets+dydrogesterone tablets<br>* Other names: Progynova+dydrogesterone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adhesion information | Intrauterine adhesions under hysteroscopy | Within the first 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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. | Within the first 3 months after surgery | 

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