Corifollitropin Alfa Versus Recombinant Follicle Stimulating Hormone (FSH) in Ovarian Stimulation of Women Undergoing in Vitro Fertilisation

NCT01319695 ↗

Phase 1/2 Completed 140 enrolled National and Kapodistrian University of Athens

Non-randomizedParallel-groupSingle-blindTreatment

Summary

The use of corifollitropin alfa is superior in terms of pregnancy outcome parameters as compared to recombinant follicle stimulating hormone (FSH) during ovarian stimulation protocols in women undergoing in vitro fertilisation.

Timeline

Start: 2011-01
Primary completion: 2016-07
Completion: 2017-08

Outcome

Missed primary endpoint

paper Live birth was determined in reduced rates in the study compared to the control group, reaching statistical significance [6/70 versus 20/70, p = 0.002] PMID 28508691 ↗

Publications

Results Siristatidis C, Dafopoulos K, Christoforidis N, Anifandis G, Pergialiotis V, Papantoniou N. Corifollitropin alfa compared with follitropin beta in GnRH-antagonist ovarian stimulation protocols in an unselected population undergoing IVF/ICSI. Gynecol Endocrinol. 2017 Dec;33(12):968-971. doi: 10.1080/09513590.2017.1323203. Epub 2017 May 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Corifollitropin alfa	Protein / enzyme biologic	100 ug	—
Subject	Corifollitropin alfa	Protein / enzyme biologic	150 ug	—
Comparator	Follitropin beta	Protein / enzyme biologic	150 iu	—
Comparator	Follitropin beta	Protein / enzyme biologic	300 iu	—