Enrolment Begins In Phase III ESPART Study


Merck has reported the enrolment of the first patient into a new Phase III study in the area of fertility. The ESPART (Evaluating the Efficacy and Safety of Pergoveris in ART) study is designed to assess the efficacy and safety of Pergoveris (follitropin alfa+lutropin alfa) versus Gonal-f (follitropin alfa) for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in women who are classified as poor ovarian responders (POR). Generally, in such patients, a low number of follicles develop during treatment, and, as a consequence, a small number of oocytes are retrieved through ART. The study aims to recruit 946 patients across 17 European countries. Pergoveris is a fixed combination of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) delivered via subcutaneous injection.

ESPART, a multicentre, randomised, controlled, single-blind Phase III trial, compares Pergoveris versus Gonal-f in patients who are classified as POR, as aligned with the outcomes of the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology. The primary endpoint of the study is total number of retrieved oocytes. Secondary endpoints include ongoing pregnancy rate, live birth rate, embryo implantation rate, clinical pregnancy rate and biochemical pregnancy rate. The design of this trial is supported by the outcomes of a meta-analysis published in February by Lehert and colleagues in the journal Reproductive Biology and Endocrinology. This analysis suggests that the combination of r-hFSH plus r-hLH during ovarian stimulation might offer a benefit to a certain subgroup of patients who are classified as POR.

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Geography: Europe, Germany