Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions (ROABTIPWSIUA)
Primary Purpose
Asherman's Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
loop-shaped intrauterine contraceptive device
intrauterine balloon (Cook Medical)
Sponsored by
About this trial
This is an interventional treatment trial for Asherman's Syndrome focused on measuring intrauterine contraceptive device, intrauterine balloon
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
Outcomes
Primary Outcome Measures
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Secondary Outcome Measures
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
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02708277
Brief Title
Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions
Acronym
ROABTIPWSIUA
Official Title
Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuqing Chen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asherman's Syndrome
Keywords
intrauterine contraceptive device, intrauterine balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.
Arm Title
Group B
Arm Type
Experimental
Arm Description
At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
Intervention Type
Device
Intervention Name(s)
loop-shaped intrauterine contraceptive device
Intervention Description
Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.
Intervention Type
Device
Intervention Name(s)
intrauterine balloon (Cook Medical)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Time Frame
three years
Secondary Outcome Measure Information:
Title
Menstruation Pattern(Improvement or No Significant Change) of All Participants
Description
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
Title
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Time Frame
Within the first 3 months after surgery
Title
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuzhong Yao, professor
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
12834941
Citation
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.
Results Reference
result
Learn more about this trial
Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions
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