Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

Summary

Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the higher circulating FSH activity during the first days of stimulation. For this reason, the use of corifollitropin alfa might be beneficial in poor responders in whom the number of oocytes retrieved is crucial for success. The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment compared to daily recFSH in terms of the number of oocytes retrieved in a defined population of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using gonadotrophin releasing hormone (GnRH) antagonists.

Timeline

Start

2011-01

Primary completion

2014-03

Completion

—

Outcome

Met primary endpoint

paper is not inferior to daily doses of 450 IU follitropin beta. PMID 25492411 ↗

paper The 95% CI of the difference between medians in the number of oocytes retrieved was -1 to +1. PMID 25492411 ↗

paper within the safety margin of 1.5. PMID 25492411 ↗

Publications

• Kolibianakis EM, Venetis CA, Bosdou JK, Zepiridis L, Chatzimeletiou K, Makedos A, Masouridou S, Triantafillidis S, Mitsoli A, Tarlatzis BC. Corifollitropin alfa compared with follitropin beta in poor responders undergoing ICSI: a randomized controlled trial. Hum Reprod. 2015 Feb;30(2):432-40. doi: 10.1093/humrep/deu301. Epub 2014 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Corifollitropin alfa	Protein / enzyme biologic	150 ug	Subcutaneous
Comparator	Recombinant human follicle stimulating hormone (r-hFSH)	Protein / enzyme biologic	450 iu	Subcutaneous

Indications