Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions

Study Overview
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Brief Summary
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The purpose of this study is to compare the outcome of loop intrauterine contraceptive device and heart-shaped intrauterine balloon for the adjunctive treatment of severe intrauterine adhesions in patients with infertility.

Detailed Description
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Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health. Currently, hysteroscopy is the preferred method of intrauterine adhesions diagnosis and treatment. However, because intrauterine adhesions patients generally have poor endometrium repair capability, the incidence rate of reformation of intrauterine adhesions ranging from 20%-62.5% in those with severe adhesions. The successful pregnancy rate after treatment in severe Asherman's syndrome is reported to be consistently lower, only 33%. The prevention of intrauterine adhesions recurrence after trans-cervical resection of adhesion is clinically important but difficult. Therefore, this study was conducted.

Official Title
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Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.

Conditions
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Asherman's Syndrome

Intervention / Treatment
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* Device: loop-shaped intrauterine contraceptive device
* Device: intrauterine balloon (Cook Medical)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of severe intrauterine adhesions infertility Exclusion Criteria: endometrial tuberculosis grossly abnormal semen analysis ovarian failure, hydrosalpinx fluid patients who did not proceed to second-look hysteroscopy within the specified time frame Women with no desire to pregnancy
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. | Device: loop-shaped intrauterine contraceptive device<br>* Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.<br>|
| Experimental: Group B<br>At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. | Device: intrauterine balloon (Cook Medical)<br>* The balloons used in this study 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 loop-shaped intrauterine contraceptive device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstruation Pattern(Improvement or No Significant Change) of All Participants | Comparing with preoperative and postoperative menstrual duration, numbers of sanitary napkin using and wet area ratio of sanitary napkin to judgment whether menstrual quantity is improvement in patients | Within the first 3 months after surgery | 
| Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound |  | Within the first 3 months after surgery | 
| Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group |  | 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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intrauterine contraceptive device, intrauterine balloon