N/A
N=93
Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions
Asherman's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02708277 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group — 12; 22 participants — p=0.009
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- loop-shaped intrauterine contraceptive device (Device); intrauterine balloon (Cook Medical) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Yuqing Chen
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group |
12; 22 | 0.009 sig |
| SECONDARY Menstruation Pattern(Improvement or No Significant Change) of All Participants |
35; 28; 8; 11 | 0.303 |
| SECONDARY Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound |
6.1; 6.1 | 0.606 |
| SECONDARY Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group |
16; 6; 13; 4; 1; 2 | 0.05 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02708277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.