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news.Merck has started enrolling patients in a new Phase III trial called ESPART, designed to evaluate the efficacy and safety of pergoveris versus Gonal-f (follitropin alfa) for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in women with poor ovarian response (POR).
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Pergoveris is a combination of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) delivered through subcutaneous injection.
The multi-center, randomized, controlled, single-blind, parallel Espart trial will enrol around 946 patients across 17 European countries.
The trial’s primary endpoint is the total number of retrieved oocytes, while secondary endpoints include ongoing pregnancy rate, live birth rate, embryo implantation rate, clinical pregnancy rate and biochemical pregnancy rate.
Merck Serono head of Clinical Development John Orloff said the ESPART trial is part of the company’s ongoing commitment to working with fertility specialists to achieve the shared goal of increasing pregnancy rates and addressing the challenges that patients face in order to help them overcome the barriers to fertility.
"As a leader in reproductive health we hope that it will help us understand how to better address the challenges faced by women with poor ovarian response," Orloff said.
The design of the Phase III trial is supported by the outcomes of a meta-analysis, which suggests that the combination of r-hFSH plus r-hLH during ovarian stimulation might provide a benefit to a certain subgroup of patients who are classified as POR.