IRIR International Research Institute for Reproduction: FLEXALIA Kopieren

A novel intra-cervical-uterine device for contraception with a  microbiocidal component

The Flexalia IUDs are based upon the widely used and CE certified Flexi-T 380 Copper IUD and the Flexi-T 300 D manufactured and distributed by PROSAN International BV., The Netherlands. The T-formed plastic frames of these devices are compatible with the uterine cavities of multiparous and nulliparous women (F-T 300 D) and created after uterine cavital measurements of lengths and widths in 795 fertile women of all age- and parity groups (1).

For the control of the presence and position, and the removal of the Flexi-T IUDs one thread only, without a knot, is integrated into the shaft of the devices.

Copper of highest purity(99.9%) is applicated at the devices a) as wire diameter .0.25 mm wrapped around the shaft and b) as sleeves fixed on the transverse arms. The Flexalia IUD has additionally spheres of-copper or silver- diameter 2.5 mm located in the small cervical cavity, the critical area, were pathological germs (bacteria, chlamydia and viruses are deposited by the sperms  of an infected sexual partner(2;9). The total surface area of the spheres is about 100 mm². It allows the reduction of the respective amount of copper surface from the IUD shaft to the “forefront, the cervical cavity/-canal. The distances between the windings of the copper wire, remaining in the endometrial cavity, are enlarged and the repair of endometrium under the influence of the follicle hormone estradiol is enhanced at the end of menstruation. (12).Another version “Flexalia II” has a copper free shaft and instead additional copper sleeves fixed at the downwardly bent ends of the transverse arms. This provides more copper and cu++ ions in the oviduct angles where sperms must pass before penetrating into the Fallopian tubes.

The “Flexalia I and II”IUDs, in relation to the proven Flexi-T IUD range will show the following advantages:

  1. Ease of insertion using the “just push in technique” without a plunger. Until today and after more than a million insertions no perforation has been reported to the manufacturer of the Flexi-T IUD Range: Prosan international, Arnhem , The Netherlands.
  2. High safety and acceptance rates due to the compatibility with the uterine cavities.
  3. High efficiency due to the laterally distributed copper sleeves(2;3) (sperms mainly migrate in the direction of the dominant follicle, in the uterine cavity laterally probably where the endometrial lining forms a semitubal canal) and due to the added metallic spheres in the cervical cavity.(4)
  4. Low rates of downward migration/expulsion due to the fundus seeking mechanism of the lateral downwardly bent ends of the transverse arms using the lateral muscle wall as support.
  5. A reduction of additional uterine bleeding e.g. the burst release in the first months after IUD-insertion and the known hypermenorrhea menorrhagia/spotting finally reduce the rates of switching to other, less effective contraceptive methods. The acceptance rates of contraception with copper IUDs will be more satisfying.

 Conclusions: Flexalia I+II are, due to the in the intra-cervical area added metal spheres (Copper or silver,) a probably enhanced effective IUD for contraception with additionally localized micro-biocidal properties against all species of germs (5; 6; 12).

Literature: 1. IN VIVO MEASUREMENTS OF UTERINE CAVITIES IN 795 WOMEN OF FERTILE AGE; Kurz, Karl H., Tadesse, A., Haspels,J., Fertil. Steril. No.6 1984

  1. Influence of Metals on in vitro Sperm Migration. Contraception Sept. 1972 vol. 6 NO 3:Kesserü al; Department of Gynecology and Obstetrics, University “Cayetano Heredia”P.O. Box2236 Lima, Peru
  2. Cochrane Review, WHO/UNFPA Meeting 19-20 September2007 in Geneva:  Conclusion: „The evidence indicates that in general copper on the arms of an IUD improves IUD efficacy”.
  3. Evaluation of active and passive transport mechanisms in the female genital tracts of IUD-bearing women with radionuclidehysterosalpingoscintigraphy.Kandanali S. et al.: Contraception 2001 Jan; 63(1): 41-5
  4. Copper is microbiocidal EPA, US-Environmental Protection Agency 29, 2008: Copper is germicidal via the oligodynamic effect. For example brass doorknobs disinfect themselves of many bacteria within a period of eight hours. Antimicrobial properties of copper are effective against MRSA, “-methicillin resistant staphylococcus aureus-“, Escherichia coli and other pathogens. Copper, when used in accordance with the label”kills 99.9% of bacteria within two hours. Copper has the intrinsic ability to kill a variety of potentially harmful pathogens”.
  5. Invasive cervical cancer and intrauterine device use. Int J Epidemiol.1991 Dec;20 (4) 865-70
  6. Inhibition of Chlamydia Trachomatis Growth in Endometrial Cells by Copper: Possible Relevance for the Use of the Copper IUD. KleinmanD. Sarov and V.Insler. Contraception 1989
  7. Intrauterine Devices and Endometrial Cancer: The WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Rosenblatt K. A., Thomas D.B. Contraception (1996) 329-39.
  8. The Role of Spermatozoa in the development of pelvic inflammatory disease in the woman. Toth A. Mac Leod Laboratory for Infertility New York Hospital, Cornell Medical Center. Advances in Contraception MTP Press Ltd., Lancaster, UK.10.Virus
  9. Virus Inactivation by Copper or Iron Ions Alone and in the Presence of Peroxide.SagripantiJ-L. et al. Applied and Environmental Microbiology Dec. 1993 p. 4374-4376American Society for Microbiology
  10. Metallic Copper as an Antimicrobial Surface. Grass, G. Rensing C. Solioz M. Appl. Environ. Microbiol. 2011 Mar,77 (5) 1541-47
  11. Vergleichende Untersuchungen zum Kupferabgabemechanismus verschiedener Cu-Intrauterinpessare. Wagner H. Die intrauterine Kontrazeption Internationales IUD-Symposium Helsinki-Kiel 1981 in memoriam Ernst Gräfenberg 100. Geburtstag
  12. Anti-microbiocidal properties of copper copper­ (numerous respective publications)
  13. Antimicrobial Polymers with Metal Nanoparticles. Palza, H.; Int.J.Mol.Sci. 2015 2099-2116 (Open access)