Merck initiates phase III fertility study with pergoveris in poor ovarian response patients

Merck has enrolled the first patient into a new phase III study in the area of fertility, marking another step in its efforts to explore innovative solutions in areas of unmet medical need. The ESPART (Evaluating the Efficacy and Safety of Pergoveris in ART) study is designed to assess 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).

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.

“The ESPART study is part of our 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,” said John Orloff, Head of Clinical Development, Merck Serono, the biopharmaceutical division of Merck. “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.”

Merck has committed itself to finding innovative solutions to develop the next generation of fertility treatments. More than 72.4 million people are affected by infertility worldwide1 and, according to the World Health Organization (WHO),2 15 per cent of couples of childbearing age seek medical help for infertility. Infertility is one of the main focus areas and an important growth driver for Merck’s largest division.

“A current trend in society is for women to delay pregnancy until later in their life and, as a consequence, women 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,” said Peter Humaidan, Aarhus University, Skive, Denmark, principal investigator of ESPART. “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.”

The ESPART Phase III multicentre, randomised, controlled, single-blind 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 (ESHRE).3 The primary endpoint of the ESPART 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 last month by Lehert and colleagues in the journal Reproductive Biology and Endocrinology.4 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.

References:
1. Boivin et al., International estimates of infertility prevalence and treatment-seeking: potential need and demand for infertility medical care, Human Reproduction Vol.22, No.6 pp. 1506–1512, 2007 doi:10.1093/humrep/dem046
2. WHO Scientific Group, Recent advances in medically assisted conception: report of a WHO scientific group. WHO Technical Report Series, No. 820. Geneva, World Health Organization, 1992
3. Ferraretti et al., ESHRE consensus on the definition of ‘poor response’ to ovarian stimulation for in vitro fertilization: the Bologna criteria; Human Reproduction, 2011; 26(7): 1616–1624
4. Lehert et al., Recombinant human follicle-stimulating hormone (r-hFSH) plus recombinant luteinizing hormone versus r-hFSH alone for ovarian stimulation during assisted reproductive technology: systematic review and meta-analysis. Reproductive Biology and Endocrinology; 2014 Feb 20;12(1):17