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

Contraception Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979835
• Other study ID #: 130717
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: March 3, 2020

Study information

• Verified date: April 2020
• Source: Wiebe, Ellen, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1030
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• GyneFix Viz
insertion of GyneFix Viz and measurment of the SA distance

Locations

Country	Name	City	State
Canada	Willow Women's Clinic	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Wiebe, Ellen, M.D.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications	Number of participants with complications and removals at the end of the 5-year follow-up period	5 years