A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)

Phase 3 Completed 259 enrolled Organon and Co

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).

Timeline

Start: 2007-05
Primary completion: 2008-12
Completion: 2008-12

Publications

Qiao J, Lu G, Zhang HW, Chen H, Ma C, Olofsson JI, Witjes H, Heijnen E, Mannaerts B. A randomized controlled trial of the GnRH antagonist ganirelix in Chinese normal responders: high efficacy and pregnancy rates. Gynecol Endocrinol. 2012 Oct;28(10):800-4. doi: 10.3109/09513590.2012.665103. Epub 2012 Mar 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ganirelix	Protein / enzyme biologic	0.25 mg	—
Comparator	Triptorelin	Other / unclassified	0.05 mg	Subcutaneous
Comparator	Triptorelin	Other / unclassified	0.1 mg	Subcutaneous

Indications

No indication recorded.