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

GYNEFIX-VIZ*: A STUDY OF SEROSAL-ANCHOR (SA) DISTANCE IN WOMEN IMMEDIATELY AND 6-8 WEEKS FOLLOWING INSERTION

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 Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: GyneFix Viz

• Study Type: Interventional
• Enrollment (Actual): 1030
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1H9
      • Willow Women's Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 46 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GF; Women who have a GyneFix Viz inserted	Device: GyneFix Viz; insertion of GyneFix Viz and measurment of the SA distance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serosal-anchor Measurement	endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus	6-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Number of participants with complications and removals at the end of the 5-year follow-up period	5 years

Collaborators and Investigators

• Sponsor: Wiebe, Ellen, M.D.
• Investigators: Principal Investigator: Ellen R WIEBE, MD, University of BC

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): March 3, 2015
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: October 26, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: intrauterine device, contraception
• Other Study ID Numbers: 130717