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Hum. Reprod. Advance Access originally published online on June 6, 2008
Human Reproduction 2008 23(8):1815-1819; doi:10.1093/humrep/den212
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© The Author 2008. 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

Randomized sibling-oocyte study using recombinant human hyaluronidase versus bovine-derived Sigma hyaluronidase in ICSI patients

A. De Vos1,3, L. Van Landuyt1, H. Van Ranst1, A. Vandermonde1, V. D’Haese1, J. Sterckx1, P. Haentjens2, P. Devroey1 and J. Van der Elst1

1 Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, B-1090 Brussels, Belgium 2 Centre for Outcomes Research, Universitair Ziekenhuis Brussel, Laboratory for Experimental Surgery, Vrije Universiteit Brussel, Laarbeeklaan 101, B-1090 Brussels, Belgium

3 Correspondence address. Tel: +32-2-477-66-97; Fax: +32-2-477-66-92; E-mail: anick.devos{at}uzbrussel.be

BACKGROUND: The enzyme hyaluronidase from bovine origin is commonly used for oocyte–cumulus cell removal in ICSI. A recombinant human hyaluronidase (rHuPH20) has been introduced as a quality-controlled and safe alternative.

METHODS: In order to validate its effectiveness, a non-inferiority trial was started on sibling cumulus–oocyte complexes (135 ICSI patients). Oocyte denudation involved enzyme incubation under Pasteur pipetting, followed by further mechanical stripping. Primary end-points were oocyte intactness after ICSI and fertilization rate. Secondary end-points were embryo development and positive hCG.

RESULTS: Oocyte intactness after ICSI was 89.6% and 92.9% with rHuPH20 and bovine hyaluronidase, respectively [absolute difference –3.3% (–7.4 to 10.7)]. The fertilization rate was 73.9% after rHuPH20 and 77.1% after bovine hyaluronidase treatment [absolute difference –3.2% (–8.3 to 1.8)]. Embryo development was similar in both treatment groups up till Day 5. Positive hCGs were equally distributed over mixed transfers 21/45 (46.7%) and transfers of only embryos from rHuPH20 treatment 17/35 (48.6%) or transfers of only embryos from bovine hyaluronidase treatment 22/48 (45.8%).

CONCLUSIONS: Our results indicate that rHuPH20 is not inferior to bovine hyaluronidase for oocyte denudation, with regard to oocyte survival and fertilization. rHuPH20 treatment of human oocytes is compatible with good embryo development, with positive hCG results and with live birth.

Key words: cumulus cell removal/hyaluronidase/ICSI prospective study

Submitted on February 25, 2008; resubmitted on April 29, 2008; accepted on May 6, 2008.


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