N/A
N=1,030
GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01979835 ↗Enrolled (actual)
1,030
Serious AEs
0.9%
Results posted
Apr 2020
Primary outcome: Primary: Serosal-anchor Measurement — 6.2 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GyneFix Viz (Device)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Wiebe, Ellen, M.D.
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serosal-anchor Measurement |
6.2 | — |
| SECONDARY Complications |
9; 36; 11; 97; 19; 95 | — |
Summary
The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.
Eligibility Criteria
Inclusion Criteria
- healthy women requesting intrauterine contraception
- willing to have a GyneFix IUD for pregnancy prevention
- able to return for a follow-up ultrasound
- able to read and understand consent form
Exclusion Criteria
- Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.)
- Immediately after a pregnancy interruption > 10 weeks gestation
Data sourced from ClinicalTrials.gov (NCT01979835). 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.