Frameless versus classical intrauterine device for contraception.

Area of Science:

• Gynecology
• Reproductive Health
• Medical Devices

Background:

• The frameless intrauterine device (IUD) utilizes a nylon thread anchored in the uterine fundus for placement, differing from classical framed IUDs.
• Copper sleeves are attached to the nylon thread for contraception.

Purpose of the Study:

• To evaluate the frameless IUD GyneFix regarding expulsion and pregnancy risks.
• To assess GyneFix's impact on bleeding and pain, common reasons for early IUD removal.

Main Methods:

• A systematic review of randomized controlled trials comparing frameless (GyneFix) and framed (TCu380) IUDs for contraception.
• Searches conducted in Cochrane Controlled Trial Register, MEDLINE, and Popline from 1980 to March 2004.
• Data extraction and analysis included calculating rate ratios and differences, with heterogeneity testing.

Main Results:

• Four trials involving 5,939 women were analyzed, with up to eight years of follow-up.
• Early trials using a prototype introducer showed higher expulsion rates.
• The large WHO trial indicated a lower pregnancy risk with the frameless device between two and six years.
• Removals for bleeding or pain did not significantly differ between frameless and framed IUDs.

Conclusions:

• Insufficient data exists to confirm if the modified GyneFix introducer resolves early expulsion issues.
• The frameless IUD demonstrates comparable performance to the TCu380, with a potentially small but significant reduction in pregnancy rates in later years.