Merck has started patient enrolment in a new Phase III trial called ESPART, designed to evaluate the efficacy and safety of Pergoveris (follitropin alfa and 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).
Pergoveris is a combination of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) delivered via subcutaneous injection.
About 946 patients across 17 European countries will be enrolled in the multi-centre, randomised, controlled, single-blind, parallel ESPART trial.
The primary endpoint of the trial is the total number of retrieved oocytes, while ongoing pregnancy rate, live birth rate, embryo implantation rate, clinical pregnancy rate and biochemical pregnancy rate constitute the trial’s secondary endpoints.
The company said that pergoveris is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency.
Merck Serono head of clinical development John Orloff said the trial is part of the company’s ongoing commitment to work 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.
According to the World Health Organization (WHO), over 72.4 million people are affected by infertility globally and 15% of them resort to medical treatments.
Professor Peter Humaidan, Aarhus University principal investigator of ESPART, said a current trend in society is for women to delay pregnancy until later in their life and, as a consequence, they may face lower chances of pregnancy due to the reduced quantity and quality of oocytes in their ovaries, thus new treatment options are needed in fertility to maximise the chances of success.
"With the ESPART study we hope to gain clarity if poor ovarian responders would benefit from the addition of recombinant LH in the protocols of stimulation, to ultimately achieve higher pregnancy rates," Humaidan 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.