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The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial

  • Olav Meirik
    Correspondence
    Corresponding author. Instituto Chileno de Medicina Reproductiva (ICMER), Jos�� Ram��n Guti��rrez No. 295 Of. 3, 8320162 Santiago, Chile.
    Affiliations
    UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, 1211 Geneva 27, Switzerland

    Instituto Chileno de Medicina Reproductiva (ICMER), 8320162 Santiago, Chile
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  • Patrick J. Rowe
    Affiliations
    Vesancy, 01170 Gex, France
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  • Alexandre Peregoudov
    Affiliations
    UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, 1211 Geneva 27, Switzerland
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  • Gilda Piaggio
    Affiliations
    UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, 1211 Geneva 27, Switzerland
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  • Max Petzold
    Affiliations
    Nordic School of Public Health, 402 42 Gothenburg, Sweden
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  • for the IUD Research Group at the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction

      Abstract

      Background

      Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared.

      Study Design

      Randomized Multicenter randomized comparative trial. Parous women requesting and eligible to use IUD were admitted in 21 centers in eight countries in 1989���1993 and followed-up for up to 8 years.

      Results

      Two thousand twenty-seven women were randomized to the frameless IUD and 2036 to TCu380A; 43 insertions of the frameless IUD failed and none for TCu380A. First-year expulsion rate of the frameless IUD was 5.3 (95% CI: 4.4���6.4) per 100 and 2.5 (95% CI: 1.9���3.3) for the TCu380A; second- through eighth-year expulsion rates were not different. First-year pregnancy rates for the frameless IUD and TCu380A were 1.3 (95% CI: 0.9���2.0) and 0.5 (95% CI: 0.3���0.9), respectively; second- through eighth-year cumulative pregnancy rates were 1.2 (95% CI: 0.7���1.9) and 2.5 (95% CI: 1.8���3.4), respectively. The 8-year cumulative rates of ectopic pregnancy and IUD removal for pain were lower for the frameless IUD than for TCu380A. Removals for other reasons were not different.

      Conclusions

      The frameless IUD had more insertion failures, expulsions and pregnancies in the first year than TCu380A, but fewer pregnancies from the second through the eighth year, and by 8 years had fewer ectopic pregnancies and removals for pain.

      Keywords

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