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

Not Applicable

Completed

• Conditions: Asherman's Syndrome
• Interventions: Device: intrauterine balloon (Cook Medical); Device: loop-shaped intrauterine contraceptive device

• Registration Number: NCT02708277
• Lead Sponsor: Yuqing Chen

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Results First Submitted: 2016-03-22
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-21
• Last Update Submitted: 2016-04-21
• Results First Posted: 2016-05-27
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	intrauterine balloon (Cook Medical)	At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.
Group A	loop-shaped intrauterine contraceptive device	At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group	three years

Secondary Outcome Measures

Name	Time	Method
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