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

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ClinicalTrials.gov Identifier: NCT02708277
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Asherman's Syndrome
Interventions Device: loop-shaped intrauterine contraceptive device
Device: intrauterine balloon (Cook Medical)
Enrollment 93
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.
Arm/Group Title Loop-shaped Intrauterine Device Group Intrauterine Balloon Group
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 50 43
Completed 43 39
Not Completed 7 4
Reason Not Completed
Lost to Follow-up             7             4
Arm/Group Title Group A Group B Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 43 39 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 39 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
 100.0%
39
 100.0%
82
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 39 participants 82 participants
32.3  (4.3) 31.6  (4.3) 31.9  (4.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 39 participants 82 participants
Female
43
 100.0%
39
 100.0%
82
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 43 participants 39 participants 82 participants
43 39 82
1.Primary Outcome
Title Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Hide Description [Not Specified]
Time Frame three years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Loop-shaped Intrauterine Device Group Intrauterine Balloon Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 43 39
Measure Type: Number
Unit of Measure: participants
12 22
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Loop-shaped Intrauterine Device Group, Intrauterine Balloon Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Menstruation Pattern(Improvement or No Significant Change) of All Participants
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Loop-shaped Intrauterine Device Group Intrauterine Balloon Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 43 39
Measure Type: Number
Unit of Measure: participants
Menstruation pattern improvement 35 28
Menstruation pattern no significant change 8 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Loop-shaped Intrauterine Device Group, Intrauterine Balloon Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Hide Description [Not Specified]
Time Frame Within the first 3 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Loop-shaped Intrauterine Device Group Intrauterine Balloon Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 43 39
Mean (Standard Deviation)
Unit of Measure: mm
6.1  (1.8) 6.1  (1.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Loop-shaped Intrauterine Device Group, Intrauterine Balloon Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.606
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Hide Description [Not Specified]
Time Frame Within the first 3 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Loop-shaped Intrauterine Device Group Intrauterine Balloon Group
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 43 39
Measure Type: Number
Unit of Measure: participants
Reformation of intrauterine adhesions 16 6
Peripheral adhesions 13 4
Central adhesions 1 2
Mixed adhesions 2 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Loop-shaped Intrauterine Device Group, Intrauterine Balloon Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Loop-shaped Intrauterine Device Group Intrauterine Balloon Group
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Loop-shaped Intrauterine Device Group Intrauterine Balloon Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Loop-shaped Intrauterine Device Group Intrauterine Balloon Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/43 (0.00%)      0/39 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Loop-shaped Intrauterine Device Group Intrauterine Balloon Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/43 (2.33%)      1/39 (2.56%)    
Infections and infestations     
vaginitis *  1/43 (2.33%)  1 1/39 (2.56%)  1
*
Indicates events were collected by non-systematic assessment
This study was conducted in a university hospital.If this was a multicenter study, the results should be more reasonable.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yuqing Chen
Organization: The First Affiliated Hospital of Sun Yat-sen University
Phone: +86 020-87755766-8341
EMail: fangchenyq@163.com
Layout table for additonal information
Responsible Party: Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02708277    
Other Study ID Numbers: IUA-21
First Submitted: March 4, 2016
First Posted: March 15, 2016
Results First Submitted: March 22, 2016
Results First Posted: May 27, 2016
Last Update Posted: May 27, 2016