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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. |
|
| Group B | Experimental | At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loop-shaped intrauterine contraceptive device | Device | Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | three years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuzhong Yao, professor | First Affiliated Hospital, Sun Yat-Sen University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12834941 | Result | Orhue AA, Aziken ME, Igbefoh JO. A comparison of two adjunctive treatments for intrauterine adhesions following lysis. Int J Gynaecol Obstet. 2003 Jul;82(1):49-56. doi: 10.1016/s0020-7292(03)00030-4. |
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Exclusion criteria: endometrial tuberculosis, grossly abnormal semen analysis, ovarian failure, hydrosalpinx fluid, and patients who did not proceed to second-look hysteroscopy within the specified time frame，women with no desire to pregnancy.
From January 2011 to February 2013, women with severe intrauterine adhesions who presented with a history of infertility were initially included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Loop-shaped Intrauterine Device Group | At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation. |
| FG001 | Intrauterine Balloon Group | At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Posted | Number | participants | three years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loop-shaped Intrauterine Device Group | At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vaginitis | Infections and infestations | Non-systematic Assessment |
This study was conducted in a university hospital.If this was a multicenter study, the results should be more reasonable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuqing Chen | The First Affiliated Hospital of Sun Yat-sen University | +86 020-87755766-8341 | fangchenyq@163.com |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| intrauterine balloon (Cook Medical) | Device | 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. |
|
| 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 |
| BG001 |
| Group B |
At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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 | Posted | Number | participants | Within the first 3 months after surgery |
|
|
|
|
| Secondary | Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound | Posted | Mean | Standard Deviation | mm | Within the first 3 months after surgery |
|
|
|
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| Secondary | Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Posted | Number | participants | Within the first 3 months after surgery |
|
|
|
|
| 0 |
| 43 |
| 1 |
| 43 |
| EG001 | Intrauterine Balloon Group | At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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. | 0 | 39 | 1 | 39 |
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| D000091662 | Genital Diseases |
| Central adhesions |
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| Mixed adhesions |
|