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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

"We hope that ESPART will help us understand how to better address the challenges faced by women with poor ovarian response."

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

"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.