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

Wiebe, Ellen, M.D.

Status: Completed

Conditions: Contraception

Treatments: Device: GyneFix Viz

Study type: Interventional

Funder types: Other

Identifiers

NCT01979835

130717

Details and patient eligibility

About

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.

Enrollment: 1,030 patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,030 participants in 1 patient group

GF

Experimental group

Description:

Women who have a GyneFix Viz inserted

Treatment:

Device: GyneFix Viz