Abstract
The CuFix (GyneFix), conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10 000 woman years of experience and upt to 8 years of follow-up in international multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. Based on new clinical information about the GyneFix from a long-term multicenter clinical trial, conducted in young nulligravid/nulliparous and parous women, the importance of this new contraceptive is discussed. The following conclusions were reached:
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- The unique design characteristics of the GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete abence of expulsion. The result is enhanced effectiveness (comparble to OCs and male/female sterilization) and a high rate of continued use. The GyneFix reduces the IUD failture rate to a minimum and is therefore, an welcome reversible alternative to OCs and female surgical contraception.
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- Framelessness and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies.
The GyneFix is a promising new, highly effective and safe, contraceptive option for parous women and an equally effective and well-accepted method for nulliparous women.
Resumé
Concu en 1985, le CuFix (GynéFix®), a été développé dans le but de minimaliser les trois causes majeures qui le plus fréquemment entrainaient d'un stérilet. Il s'agit de l'expulsion, des saignements/ménorragis et des douleurs.
Depuis le premières investigations cliniques investigation, plus de 10.000 années-femmes out pu être collectées et une expérience de plus de 8 ans à été acquise dans des études internationales, multicentriques, comparatives et non-comparatives et dont une large part chez des nulligestes. Sur la base d'une étude clinique multicentrique chez des jeunes femmes nulligestes et des femmes qui ont eu des enfants, de nouvelles informations cliniques faites avec le GynéFix, démontrent l'importance du nouveau contraceptif.
Le présent article a pour but de présenter les conclusions. Celles-ci sont:
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- Les caractéristiques du GynéFix, à savoir: absence de matrice en plastique, grande flexibilité et fixation permanente dans la paroi du fond utérin; entrainent une tolérance optimale et une absence quasi-totale d'expulsion. On enrégistre dès lors, une efficacité supérieure à celle obtenue avec des stérilets classiques (comparable à la pilule et à la stérilisation masculine ou féminine) ainsi qu'un taux élevé de continuation. Le GynéFix réduit donc le taux d'échec au minimum et est, pour cette raison, une alternative qui arrive à propos pour la pilute et la contraception chirurgicale.
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- L'absence d'un squelette en plastique et la grande flexibilité du GynéFix réduisent les effects secondaires et annihilent les complications dues à une incompatibilité dimensionelle entre le squelette d'un stérilet et la cavité utérine. Les études effectuées avec le GynéFix permettent également de constater l'absence de complications infectieuses, telle le salpingite, et les grossesses extra-utérines.
Le GynéFix est un nouveau dispositif contraceptif important. En plus d'être bien tolére, bien retenu par l'utérus, sûr et efficace, il est le meilleur choix pour une contraception intra-utérine chez les nulligestes.
Resumen
El CuFix (GyneFix®), ideado en 1985, se desarrolló para minimizar tres de los problema más importantes asociados con mayor frecuencia a la discontinuación del uso de un DIU: expulsión, sangrado y dolor. Desde que se iniciaron los primeros estidios clinicos, se han recogido unos 10.000 años-mujer de uso y hasta 8 años de seguimiento en ensayos clinicos internacionales, multicentricos, comparativos y no-comparativis, incluyendo una gran proporción de mujeros nuliparas-nulligrávidas. Se discuto en este articulo la importancia clinica sibre el GyneFix en los estudios multicéntricos, realizados en mujeres nuliparasnulligrávidas y mujere multiparas.
Se ha llegado a las siguientes conclusiones:
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- Las caracteristicas de diseño del GyneFix (sin estructura rigida, flexible y figado a fundus uterino) han contribuido par conseguir una tolerancia optima con una ausencia casi total de expulsiones. Como consecuenci existe un aumento de la eficia (comparado con los anticonceptivos orales y esterilización masculina/feminina) y una elevada tasa de continuación de uso. El GyneFix disminuye la tasa de fallos del DIU al minimo y por tanto es un método contraceptivo que supone una excelente alternativa a los contraceptivos orales y la contracepción quirúrgica.
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- La ausencia de estructura rigida y la flexibilidad explicarian la auscencia de efectos secundarios y reacciones adveras provocadas por la incompatibilidad dimensional entre los DIUs de estructura rigida y la cavidad uterina, y tambien podia explica la auscencia de Enfermedad Inflamatoria Pévica y embarzos ectópicos en todos los estudios clinicos.
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van Kets, H., Vrijens, M., van Trappen, Y. et al. The frameless GyneFix® intrauterine implant: A major improvement in efficacy, expulsion and tolerance. Adv Contracept 11, 131–142 (1995). https://doi.org/10.1007/BF01987278
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DOI: https://doi.org/10.1007/BF01987278