GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance

N/ACompletedNCT01979835

Wiebe, Ellen, M.D.1,030 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

1,030

Conditions

Contraception

Interventions

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. healthy women requesting intrauterine contraception 2. willing to have a GyneFix IUD for pregnancy prevention 3. able to return for a follow-up ultrasound 4. able to read and understand consent form Exclusion Criteria: 1. Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.) 2. Immediately after a pregnancy interruption \> 10 weeks gestation

Outcomes

Primary Outcomes

Serosal-anchor Measurement

endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus

Time frame: 6-8 weeks

Secondary Outcomes

Complications

Number of participants with complications and removals at the end of the 5-year follow-up period

Time frame: 5 years