Craig Witz, Eric D. Foster, Sarah A. Grover, Patrick W. Heiser, CLARA (Comparison of MENOPUR Liquid and Powder in Women Undergoing ART) trial group
{"title":"Human menopausal gonadotrophin in a pre-filled injection pen is non-inferior to the US-approved powder formulation","authors":"Craig Witz, Eric D. Foster, Sarah A. Grover, Patrick W. Heiser, CLARA (Comparison of MENOPUR Liquid and Powder in Women Undergoing ART) trial group","doi":"10.1016/j.rbmo.2026.105743","DOIUrl":"10.1016/j.rbmo.2026.105743","url":null,"abstract":"<div><h3>Research question</h3><div>Is non-inferiority demonstrated for highly purified human menopausal gonadotrophin (HP-HMG) in an injection pen versus the US approved HP-HMG powder formulation for number of fertilized oocytes in women undergoing ovarian stimulation?</div></div><div><h3>Design</h3><div>Randomised, double-blind, double-dummy, parallel group, multicentre, non-inferiority trial at 19 US reproductive medicine centres enrolling 401 women ages 18‒42 years, randomised 1:1 to HP-HMG pen or HP-HMG powder. After downregulation in a gonadotropin-releasing hormone agonist (GnRHa) cycle, ovaries were stimulated with HP-HMG pen or HP-HMG powder at a starting dose of 225 IU for the first 5 days, with subsequent dose adjustments as needed. The number of fertilized (two pronuclei [2PN]) oocytes 19 ± 2 h after insemination was the primary end point.</div></div><div><h3>Results</h3><div>The primary end point was met, and HP-HMG pen was non-inferior to HP-HMG powder, with the mean ± SD number of fertilized 2PN oocytes 8.2 ± 5.5 and 6.6 ± 4.3, respectively (adjusted treatment difference: 1.50, 95% CI 0.57 to 2.42). The number of oocytes retrieved was 14.3 ± 8.1 with HP-HMG pen and 11.4 ± 6.3 with HP-HMG powder. The mean number of blastocysts was 4.8 ± 3.8 in the HP-HMG pen group and 3.9 ± 3.0 in the HP-HMG powder group. The ongoing pregnancy rate per started stimulation cycle was 45.0% in the HP-HMG pen group and 42.7% in the HP-HMG powder group and the live birth rate was 44.1% and 42.2% after fresh transfer, respectively. The incidence of early ovarian hyperstimulation syndrome was 3.5% in both groups.</div></div><div><h3>Conclusions</h3><div>HP-HMG as a solution for injection in a pre-filled injection pen is an effective and safe alternative to the approved powder formulation.</div></div>","PeriodicalId":21134,"journal":{"name":"Reproductive biomedicine online","volume":"53 4","pages":"Article 105743"},"PeriodicalIF":3.9,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148219586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Inside Front Cover - First page of TOC","authors":"","doi":"10.1016/S1472-6483(26)00481-5","DOIUrl":"10.1016/S1472-6483(26)00481-5","url":null,"abstract":"","PeriodicalId":21134,"journal":{"name":"Reproductive biomedicine online","volume":"53 4","pages":"Article 105940"},"PeriodicalIF":3.9,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149153513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Inside Front Cover - First page of TOC","authors":"","doi":"10.1016/S1472-6483(26)00442-6","DOIUrl":"10.1016/S1472-6483(26)00442-6","url":null,"abstract":"","PeriodicalId":21134,"journal":{"name":"Reproductive biomedicine online","volume":"53 3","pages":"Article 105901"},"PeriodicalIF":3.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148934538","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Inside Front Cover - First page of TOC","authors":"","doi":"10.1016/S1472-6483(26)00390-1","DOIUrl":"10.1016/S1472-6483(26)00390-1","url":null,"abstract":"","PeriodicalId":21134,"journal":{"name":"Reproductive biomedicine online","volume":"53 2","pages":"Article 105849"},"PeriodicalIF":3.9,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148656920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}