Live birth has increasingly been identified as the standard clinical approach to measure the success of medically assisted reproduction (MAR). However, previous analyses comparing biosimilar preparations of follitropin alfa versus the reference product (GONAL-f®, Merck KGaA, Darmstadt, Germany or GONAL-f® RFF; EMD Serono, Inc., Rockland, MA), have had insufficient power to detect differences in clinically meaningful outcomes such as live birth.
Authors would like to thank Dr. Rui Wang (Department of Obstetrics and Gynecology, University of Monash) who contributed to the statistical analysis. Medical writing assistance was provided by Evelina Matekonyte, inScience
Communications, Springer Healthcare Ltd., London, UK, and funded by Merck KGaA, Darmstadt, Germany.
This study was funded by Merck KGaA, Darmstadt, Germany. Merck KGaA (Darmstadt, Germany) designed and approved the study, took part in data collection and data analysis, and contributed to the data interpretation and final draft of the manuscript. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
- Follitropin alfa
- Ovarian stimulation