Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 93
- Primary Endpoint
- Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group
Time Frame: three years
Secondary Outcomes
- Menstruation Pattern(Improvement or No Significant Change) of All Participants(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)
- Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound(Within the first 3 months after surgery)
Investigators
Yuqing Chen
Associate chief physician
First Affiliated Hospital, Sun Yat-Sen University