The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions

Study Overview
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Brief Summary
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To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.

Detailed Description
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Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention

Official Title
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The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions

Conditions
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Intrauterine Adhesions

Intervention / Treatment
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* Procedure: dried biological amnion graft
* Device: Foley balloon
* 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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Accepts Healthy Volunteers

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: dried biological amnion graft<br>patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. | Procedure: dried biological amnion graft<br>* Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane<br>* Other names: Uterine application of amnion membrane;Device: Foley balloon<br>* Device: Foley balloon Uterine application of Foley balloon<br>* Other names: Device: Foley balloon Uterine application of Foley balloon;Drug: estradiol valerate tablets+dydrogesterone Tablets<br>* oral estradiol valerate tablets+dydrogesterone Tablets<br>* Other names: Progynova+dydrogesterone;|
| Sham Comparator: Foley catheter balloon only<br>patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. | Device: Foley balloon<br>* Device: Foley balloon Uterine application of Foley balloon<br>* Other names: Device: Foley balloon Uterine application of Foley balloon;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 |
| --- | --- | --- |
| second diagnostic hysteroscopy |  | postoperation three to four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amnion graft, New biological barrier system