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Hum. Reprod. Advance Access originally published online on June 23, 2007
Human Reproduction 2007 22(9):2481-2487; doi:10.1093/humrep/dem180
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© The Author 2007. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Impact of Italian legislation regulating assisted reproduction techniques on ICSI outcomes in severe male factor infertility: a multicentric survey

R. Ciriminna1,11, M.L. Papale2, P.G. Artini3, M. Costa4, L. De Santis5, L. Gandini6, L. Parmegiani7, G. Ragni8, A. Revelli9, L. Rienzi on behalf of the Italian Society of Embriology, Reproduction and Research (SIERR)10,*

1 A.M.B.R.A., Associazione Medici e Biologi per la Riproduzione Assistita, Palermo, Italy 2 CRA, Centro Riproduzione Assistita, Catania, Italy 3 Centro di Fisiopatologia della Riproduzione e Procreazione Assistita, Pisa, Italy 4 Struttura Semplice Diagnosi e Terapia dell'Infertilità E.O. Ospedali Galliera, Genova, Italy 5 U.O. Scienze Natalità—Fisiopatologia Riproduzione H.S.Raffaele, Milano (Milano I), Italy 6 ARS Biomedica, Roma (Roma I), Italy 7 GynePro Medicina della Riproduzione, Bologna, Italy 8 Infertility Unit, Fondazione Policlinico-Mangiagalli, Milano (Milano II), Italy 9 Centro di Medicina della Riproduzione Universita' di Torino Az. OIRM-S.Anna, Torino, Italy 10 Medicina e Biologia della Riproduzione, European Hospital, Roma (Roma II), Italy

11 To whom correspondence should be addressed at: A.M.B.R.A, Associazione Medici e Biologi per la Riproduzione Assistita, Via G. De Spuches, 11 90141 Palermo, Italy. Tel: +39 091 6127014; Fax: +39 091 6813313; E-mail: rosanna.ciriminna{at}gmail.com

BACKGROUND: In 2004, a law regulating assisted reproduction techniques (ART) was passed in Italy. The new rules allow for the formation and transfer of a maximum of three embryos at one time, whereas embryo selection and embryo storage are prohibited. The aim of this study is to evaluate the impact of these restrictions on ICSI outcome in couples affected by severe male factor infertility.

METHODS: Thirteen Italian ART Units were involved in this study. Data were collected on ICSI cycles performed during 2 years before (control group) and 2 years after (study group) the enforcement of the law. Only cases of obstructive azoospermia (OA), non-obstructive azoospermia (NOA) and severe oligoastenoteratozoospermia (OAT) (sperm count ≤1 x 106 per ml; normal forms ≤5% according to WHO) were included. Laboratory results (fertilization rate, cleavage rate and embryo quality) and clinical outcomes (clinical pregnancy rate, implantation rate, abortion rate) were compared between the two groups.

RESULTS: One thousand six hundred and forty ICSI cycles were examined. The control group included 843 cycles (51.4%), whereas the study group consisted in 797 cycles (48.6%). The restrictions imposed by the law significantly reduced the number of good-morphology embryos available for transfer (57.5 versus 50.1%; P < 0.001). In addition, the clinical pregnancy rate (32.6 versus 22.6%; P < 0.001) and the implantation rate (16.0 versus 12.3%; P< 0.05) per cycle were negatively affected by the enforcement of the law. In particular, dramatic reductions in the pregnancy rate (36.6 versus 15.5%; P < 0.001) and the implantation rate (17.8 versus 9.8%; P < 0.001) were observed in the NOA subgroup.

CONCLUSIONS: Limiting the number of treated oocytes to three per ICSI cycle significantly reduces the chance of transferring good quality embryos and thus achieving a pregnancy in cases of severe male factor infertility. NOA patients are particularly affected by this restriction imposed by the new Italian law.

Key words: legislation/ART/ICSI/azoospermia/pregnancy rate

* Collaborators in the Italian Society of Embriology, Reproduction and Research (SIERR) were: R. Barbaro (A.M.B.R.A., Associazione Medici e Biologi per la Riproduzione Assistita, Palermo, Italy); V. Cela (Centro di Fisiopatologia della Riproduzione e Procreazione Assistita, Pisa, Italy); I. Cino (U.O. Scienze Natalitá - Fisiopatologia Riproduzione H.S. Raffaele, Milano, Italy); D. Colia (Struttura Semplice Diagnosi e Terapia dell'Infertilitá E.O. Ospedali Galliera, Genova, Italy); G. D'Ambrogio (Centro di Fisiopatologia della Riproduzione e Procreazione Assistita, Lecce, Italy); L. Diotallevi (Centro Medico Palladio, Vicenza, Italy); M. Dusi (Centro Medico Palladio, Vicenza, Italy); M. Filicori (GynePro Medicina della Riproduzione, Bologna, Italy); A.R. Genazzani (Centro di Fisiopatologia della Riproduzione e Procreazione Assistita, Pisa, Italy); G. Giuffrida (CRA Centro Riproduzione Assistita, Catania, Italy); F. Lombardo (ARS Biomedica, Roma, Italy); A. Paffoni (Infertility Unit, Fondazione Policlinico-Mangiagalli, Milano, Italy); C. Racca (Centro di Medicina della Riproduzione Universita' di Torino Az. OIRM-S.Anna, Torino, Italy); E. Greco (Medicina e Biologia della Riproduzione, European Hospital, Roma, Italy).

Submitted on April 3, 2007; resubmitted on May 21, 2007; accepted on May 23, 2007.


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