A randomized controlled trial of the GnRH antagonist ganirelix in Chinese normal responders: high efficacy and pregnancy rates

Abstract

Gonadotropin-releasing hormone (GnRH) antagonists for controlled ovarian stimulation (COS) were only recently introduced into China. The efficacy and safety of the GnRH antagonist ganirelix was assessed in a multicenter, controlled, open-label study, in which Chinese women were randomized to either ganirelix (n = 113) or a long GnRH agonist protocol of triptorelin (n = 120). The primary end point was the amount of recombinant follicle-stimulating hormone (rFSH) required to meet the human chorionic gonadotropin criterion (three follicles ≥17 mm). The amount of rFSH needed was significantly lower for ganirelix (1272 IU) vs. triptorelin (1416 IU; P< 0.001). Ongoing pregnancy rates per started cycle were 39.8% (ganirelix) and 39.2% (triptorelin). Although both treatments were well tolerated, cancellation due to risk of ovarian hyperstimulation syndrome (OHSS) was less frequent with ganirelix (1.8%) than triptorelin (7.5%) (P = 0.06). Less rFSH was needed in the ganirelix protocol than the long GnRH agonist protocol, with fewer reported cases of OHSS and similar pregnancy rates.

Keywords::

• GnRH agonist
• GnRH antagonist
• ganirelix
• IVF
• ICSI
• rFSH
• triptorelin

Declaration of Interest: Medical writing and editorial assistance was provided by Sally-Anne Mitchell, PhD, of PAREXEL, UK. This assistance was funded by Merck, Sharp and Dohme & Co. (Whitehouse Station, NJ, USA), who also funded this study, clinical trial identifier: NCT00725491. JIO, HW, EH and BM are employees of Merck, Sharp and Dohme & Co.