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Completed

NCT Number: NCT01979835

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

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.

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Key information

Conditions

Contraception

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Willow Women's Clinic

Vancouver, British Columbia, V5Z1H9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GyneFix Viz

Device

insertion of GyneFix Viz and measurment of the SA distance

Primary outcomes

  1. Serosal-anchor Measurement

    Time frame: 6-8 weeks

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

Secondary outcomes

  1. Complications

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Wiebe, Ellen, M.D.

Other

Registry information

Official study title

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

Acronym: GF

Important dates

Study start
2013
Primary completion
2015
Study completion
2020
First posted
Nov 8, 2013
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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