Date: 2014-03-27
Type of information:
phase: 3
Announcement: enrollment of the first patient
Company: Merck KGaA (Germany)
Product: Pergoveris® (follitropin alfa and lutropin alfa)
Action
mechanism: Pergoveris® is the first combined product of recombinant human follicle stimulating hormone (r-hFSH or follitropin alfa 150 IU) and recombinant human luteinizing hormone (r-hLH or lutropin alfa 75 IU).
Disease: Assisted Reproductive Technology (ART) treatment cycle in women who are classified as poor ovarian responders
Therapeutic area: Gynecology - Women\'s health
Country: 17 European countries (Belgium,Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, The Netherlands, Poland, Russia, Spain, Sweden, Turkey, UK)
Trial
details: The ESPART Phase III clinical 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).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 in February 2014 by Lehert and colleagues in the journal Reproductive Biology and Endocrinology (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). (NCT02047227)
Latest
news: * On March 27, 2014, Merck KGaA has announced the enrollment of the first patient into a new Phase III study in the area of fertility.The ESPART* 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). 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 design of this trial is supported by the outcomes of a meta-analysis published in February 2014 by Lehert and colleagues in the journal Reproductive Biology and Endocrinology (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).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 poor ovarian responders. The Lehert meta-analysis reviewed data from 43 randomized controlled trials, investigating 6443 patients. The results of this meta-analysis showed no significant differences in the number of oocytes retrieved for the overall patient population, between the r-hFSH plus r-hLH and r-hFSH groups (weighted mean difference ?0.03; 95% confidence interval [CI] ?0.41 to 0.34). However, in POR patients treated with r-hFSH plus r-hLH, significantly more oocytes were retrieved than with r-hFSH alone (n = 1077; weighted mean difference +0.75 oocytes; 95% CI 0.14–1.36). Additionally, a significantly higher clinical pregnancy rate was observed with r-hFSH plus r-hLH versus r-hFSH alone, not only in the overall patient population analysed (risk ratio [RR] 1.09; 95% CI 1.01–1.18) but also in POR patients, where these differences were even more pronounced (n = 1179; RR 1.30; 95% CI 1.01–1.67; ITT population).
