Randomized controlled trial comparing highly purified (HP-hCG) and recombinant hCG (r-hCG) for triggering ovulation in ART

Abstract

Background: A randomized controlled trial (RCT) comparing highly purified human Choriogonadotrophin (HP-hCG) and recombinant hCG (r-hCG) both administered subcutaneously for triggering ovulation in controlled ovarian stimulation (COS) for Assisted Reproductive Technology (ART). Methods: Multi-centre (n = 4), prospective, controlled, randomized, non-inferiority, parallel group, investigator blind design, including 147 patients. The trial was registered with www.clinicaltrials.gov, using the identifier: NCT00335569. The primary endpoint is the number of oocytes retrieved, while the secondary endpoints include embryo implantation, pregnancy and delivery rates as well as safety parameters. Results: The number of retrieved oocytes was not inferior when HP-hCG was used as compared to r-hCG: the mean number was 13.3 (6.8) in HP-hCG and 12.5 (5.8) in the r-hCG group (p = 0.49) with a 95% CI (−1.34, 2.77). Regarding the secondary outcomes, there were also no differences in fertilization rate at 57.3% (467/815) vs. 61.3% (482/787) (p = 0.11), the number of embryos available for transfer and cryopreservation (2PN stage) and implantation, pregnancy and delivery rates. Furthermore, there were no differences in the number and type of adverse events reported. HP-hCG was therefore not inferior to r-hCG. Conclusions: HP-hCG and r-hCG are equally efficient and safe for triggering ovulation in ART and, both being administered subcutaneously, equally practical and well tolerated by patients.

Keywords::

• COH
• hCG
• highly purified
• triggering ovulation

Acknowledgements

We thank the expert help of Marie-Andrée Poirier, Francine Benoit, Mirka Pavlik, Daniela Widmer (study nurses), and Mariafrancesca Loporchio (clinical trial co-ordinator). We would also like to thank Silvia Trevisan and Costanzo Limoni for their expert statistical support. M. Bellavia participated in execution of trial, analysis of data and critical discussion. C. de Geyter participated in execution of trial, analysis of data and critical discussion. M. I. Streuli participated in drafting and re-reading of manuscript and critical discussion. V. Ibecheole participated in execution of trial and critical discussion. M. H. Birkhäuser participated in execution of trial and critical discussion. B. Cometti participated in study design, execution of trial, analysis of data and critical discussion. D. de Ziegler participated in execution of trial, analysis of data, drafting of manuscript and critical discussion. Martin Birkhäuser is a member of the advisory boards for menopause and osteoporosis for Pfizer, Daiichi Sankyo, MSD, AMGEM.

Declaration of Interest: This study was sponsored and monitored by IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland. Dominique De Ziegler holds equity in Ultrast Inc., is recipient of study grants from Schering Plough and Ferring Laboratories and is consulting for IBSA Institut Biochimique SA. All the other authors report no conflicts of interest.