Research Paper Volume 12, Issue 6 pp 4918—4930
Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer
- 1 The First Affiliated Hospital of Zhengzhou University, Reproductive Medicine, Zhengzhou, China
- 2 Sir Run Run Shaw Hospital of Zhejiang University, Reproductive Medicine, Hangzhou, China
- 3 Southern Medical University, Reproductive Medicine, Guangzhou, China
- 4 Second Affiliated Hospital of Wenzhou Medical University, Reproductive Medicine, Wenzhou, China
- 5 Peking University Shenzhen Hospital, Reproductive Medicine, Shenzhen, China
- 6 Hainan Medical College, Reproductive Medicine, Haikou, China
Received: November 18, 2019 Accepted: March 3, 2020 Published: March 25, 2020https://doi.org/10.18632/aging.102919
How to Cite
Copyright © 2020 Hu et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
To compare the ovarian responses after administration of two recombinant follicle-stimulating hormone (r-FSH) preparations under gonadotropin-releasing hormone (GnRH) analogue downregulation, we conducted a phase 3, randomized, multicenter, assessor-blind, active-controlled, parallel group study. The primary outcome was the number of oocytes retrieved. The secondary outcomes included total dose and duration of r-FSH administered, oocyte quality, blood estradiol levels, follicular development, fertilization rates, implantation rates, and pregnancy rates (biochemical, clinical, and ongoing). A total of 451 patients with infertility were randomized to receive either Follitrope™ Prefilled Syringe or Gonal-F® Pen for ovarian stimulation. The mean number of oocytes retrieved was 14.9 in the FollitropeTM Prefilled Syringe group, and 12.8 in the Gonal-F® Pen group. The 95% confidence interval in the oocyte number difference between the groups was [–0.1, 4.2], demonstrating that FollitropeTM Prefilled Syringe was not inferior to Gonal-F® Pen. The clinical pregnancy rates (FollitropeTM Prefilled Syringe vs. Gonal-F® Pen: 55.4% vs. 51.9%) and ongoing pregnancy rates (44.1% vs. 43.0%) were similar between the groups. No clinically significant adverse events were observed in either group. In summary, our study indicates that FollitropeTM Prefilled Syringe is safe and efficacious for ovarian stimulation.