Efficacy and safety of newly developed ganirelix acetate in infertile women for assisted reproductive technology: a prospective, randomised, controlled study
Creators: name: Han, E. Jung
name: Lyu, Sang Woo
name: Kwak, In Pyung
name: Kwon, Hwang
name: Choi, Dong Hee
name: Kim, Jin Young
name: Park, Han Moie
name: Kim, Ji Won
name: Chang, Eun Mi
name: Lee, Hee Jun
name: Kim, Min Kyung
name: Lee, Hye Nam
name: Kim, Jeong Yun
name: La Park, So
name: Lee, Woo Sik
Publisher: name: Taylor & Francis
Year: 2022
Subjects: subject: Medicine
subject: Physiology
subject: FOS: Biological sciences
subject: Chemical Sciences not elsewhere classified
subject: Immunology
subject: FOS: Clinical medicine
subject: Mathematical Sciences not elsewhere classified
subject: Developmental Biology
subject: Cancer

description: This study aimed to investigate the efficacy of Ganilever pre-filled syringe (PFS), a newly developed ganirelix acetate, for the inhibition of premature luteinising hormone (LH) surge in <i>in vitro</i> fertilisation (IVF). A prospective randomised controlled study was conducted (NCT03051087). A total of 236 women (Ganilever group: 114, Orgalutran group: 122) were finally analysed. The patients with LH of &gt;10 mIU/mL on the day of human chorionic gonadotropin (hCG) injection were 0 (0.0%) and 3 (2.5%) in the Ganilever and Orgalutran groups, respectively (<i>p</i>= .25). The number of retrieved oocytes from two groups did not show any significant difference (12.0 ± 6.4 vs. 11.8 ± 6.3, <i>p</i>= .73). Furthermore, the two groups did not show significant differences in the number of good-quality oocytes and embryo, and the rate of fertilisation. Similar safety profiles were also observed. In conclusion, Ganilever PFS showed comparable IVF outcomes and safety profile in IVF, as compared to the Orgalutran. Impact Statement<b>What is already known on this subject?</b> Premature LH surge during controlled ovarian stimulation results in the induction of luteinisation of the immature follicles. Thus, gonadotrophin-releasing hormone (GnRH) antagonist protocol was suggested as an option for suppression of premature LH surge. Currently, one of GnRH antagonists being widely used is ganirelix acetate (Orgalutran<sup>®</sup>; Organon, Oss, The Netherlands). Ganilever pre-filled syringe (PFS) is a newly developed GnRH antagonist containing ganirelix acetate as an active ingredient.<b>What do the results of this study add?</b> Our study demonstrated that Ganilever PFS showed comparable IVF outcomes and patient safety profile in infertile women undergoing in IVF-ET, as compared to the Orgalutran.<b>What are the implications of these findings for clinical practice and/or further research?</b> The results of our study will provide another available GnRH antagonist to be used in patients with IVF. <b>What is already known on this subject?</b> Premature LH surge during controlled ovarian stimulation results in the induction of luteinisation of the immature follicles. Thus, gonadotrophin-releasing hormone (GnRH) antagonist protocol was suggested as an option for suppression of premature LH surge. Currently, one of GnRH antagonists being widely used is ganirelix acetate (Orgalutran<sup>®</sup>; Organon, Oss, The Netherlands). Ganilever pre-filled syringe (PFS) is a newly developed GnRH antagonist containing ganirelix acetate as an active ingredient. <b>What do the results of this study add?</b> Our study demonstrated that Ganilever PFS showed comparable IVF outcomes and patient safety profile in infertile women undergoing in IVF-ET, as compared to the Orgalutran. <b>What are the implications of these findings for clinical practice and/or further research?</b> The results of our study will provide another available GnRH antagonist to be used in patients with IVF.