Asherman's Syndrome
Conditions
Keywords
intrauterine contraceptive device, intrauterine balloon
Brief summary
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
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.
Interventions
DEVICEloop-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.
DEVICEintrauterine 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.
Sponsors
Yuqing Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | three years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstruation Pattern(Improvement or No Significant Change) of All Participants | Within the first 3 months after surgery | 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 |
| 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 | — |
Participant flow
Recruitment details
From January 2011 to February 2013, women with severe intrauterine adhesions who presented with a history of infertility were initially included in the study.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 39 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 4 |
Baseline characteristics
| Characteristic | Group B | Group A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 43 Participants | 82 Participants |
| Age, Continuous | 31.6 years STANDARD_DEVIATION 4.3 | 32.3 years STANDARD_DEVIATION 4.3 | 31.9 years STANDARD_DEVIATION 4.3 |
| Region of Enrollment China | 39 participants | 43 participants | 82 participants |
| Sex: Female, Male Female | 39 Participants | 43 Participants | 82 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 43 | 1 / 39 |
| serious Total, serious adverse events | 0 / 43 | 0 / 39 |
Outcome results
Primary
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Time frame: three years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loop-shaped Intrauterine Device Group | Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | 12 participants |
| Intrauterine Balloon Group | Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | 22 participants |
p-value: 0.009Chi-squared
Secondary
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Time frame: Within the first 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loop-shaped Intrauterine Device Group | Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound | 6.1 mm | Standard Deviation 1.8 |
| Intrauterine Balloon Group | Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound | 6.1 mm | Standard Deviation 1.7 |
p-value: 0.606t-test, 2 sided
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
Time frame: Within the first 3 months after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loop-shaped Intrauterine Device Group | Menstruation Pattern(Improvement or No Significant Change) of All Participants | Menstruation pattern improvement | 35 participants |
| Loop-shaped Intrauterine Device Group | Menstruation Pattern(Improvement or No Significant Change) of All Participants | Menstruation pattern no significant change | 8 participants |
| Intrauterine Balloon Group | Menstruation Pattern(Improvement or No Significant Change) of All Participants | Menstruation pattern no significant change | 11 participants |
| Intrauterine Balloon Group | Menstruation Pattern(Improvement or No Significant Change) of All Participants | Menstruation pattern improvement | 28 participants |
p-value: 0.303Chi-squared
Secondary
Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Time frame: Within the first 3 months after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Loop-shaped Intrauterine Device Group | Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Mixed adhesions | 2 participants |
| Loop-shaped Intrauterine Device Group | Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Peripheral adhesions | 13 participants |
| Loop-shaped Intrauterine Device Group | Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Reformation of intrauterine adhesions | 16 participants |
| Loop-shaped Intrauterine Device Group | Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Central adhesions | 1 participants |
| Intrauterine Balloon Group | Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Reformation of intrauterine adhesions | 6 participants |
| Intrauterine Balloon Group | Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Mixed adhesions | 0 participants |
| Intrauterine Balloon Group | Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Central adhesions | 2 participants |
| Intrauterine Balloon Group | Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group | Peripheral adhesions | 4 participants |
p-value: 0.05Chi-squared