Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)

Summary

This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone \[r-hFSH\]/recombinant human luteinising hormone \[r-hLH\]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.

Timeline

Start

2014-01-31

Primary completion

2015-08-31

Completion

2015-08-31

Publications

• Results Humaidan P, Chin W, Rogoff D, D'Hooghe T, Longobardi S, Hubbard J, Schertz J; ESPART Study Investigatorsdouble dagger. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders. Hum Reprod. 2017 Mar 1;32(3):544-555. doi: 10.1093/humrep/dew360.
• Humaidan P, Schertz J, Fischer R. Efficacy and Safety of Pergoveris in Assisted Reproductive Technology--ESPART: rationale and design of a randomised controlled trial in poor ovarian responders undergoing IVF/ICSI treatment. BMJ Open. 2015 Jul 3;5(7):e008297. doi: 10.1136/bmjopen-2015-008297.

Drugs

Indications