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
|Condition or disease||Intervention/treatment||Phase|
|Asherman's Syndrome||Device: loop-shaped intrauterine contraceptive device Device: intrauterine balloon (Cook Medical)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: Group A
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
Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.
Experimental: Group B
At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
Device: 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.
- Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group [ Time Frame: three years ]
- Menstruation Pattern(Improvement or No Significant Change) of All Participants [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Within the first 3 months after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708277
|Study Director:||Shuzhong Yao, professor||First Affiliated Hospital, Sun Yat-Sen University|