Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

Study Overview
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Brief Summary
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This study was taken out to compare two mechanical devices (intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.

Detailed Description
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Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both effective in the therapy for intrauterine adhesion. The Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed two or three month later. The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Official Title
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A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device Plus Foley Catheter in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis

Conditions
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Asherman Syndrome

Intervention / Treatment
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* Device: Intrauterine balloon
* Device: Intrauterine Contraceptive Device Plus Foley Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe intrauterine adhesion (AFS score ≥5） Agreement to have a second-look hysteroscopy no previous history of hysteroscopic adhesiolysis Exclusion Criteria: Minimal adhesion (AFS score<5) Previous hysteroscopic adhesiolysis

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrauterine balloon<br>The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two or three months to re-evaluate the uterine adhesions. | Device: Intrauterine balloon<br>* After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.<br>* Other names: Cook balloon;|
| Experimental: intrauterine device Plus Foley Catheter<br>Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy. | Device: Intrauterine Contraceptive Device Plus Foley Catheter<br>* After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.<br>* Other names: Intrauterine Device Plus Foley Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the AFS Score at Second-look Hysteroscopy | The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is. | 2 or 3 months after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asherman Syndrome, intrauterine balloon, Intrauterine Device Plus Foley Balloon Catheter