Ovarian stimulation with corifollitropin alfa followed by hp-hMG compared to hp-hMG in patients at risk of poor ovarian response undergoing ICSI: A randomized controlled trial

Data de publicació: 01/12/2018

Autors de IIS La Fe

Autors aliens a IIS La Fe

Ferreros, I

Grups d'Investigació

Medicina Reproductiva

Investigador Principal

José Morales Roselló

Abstract

Objective: To compare the results of two ovarian stimulation protocols for IVF in patients at risk of poor ovarian response: corifollitropin alfa followed by hp-hMG versus daily administration of hp-hMG. We intended to demonstrate the non-inferiority of the protocol with corifollitropin alfa. Study design: This is a prospective, randomized, non-inferiority, controlled study. We compared two ovarian stimulation protocols for IVF in 234 patients, under 40 years of age and at risk of poor ovarian response. First protocol was a single injection of 150 mu g corifollitropin alfa and the second, a daily injection of 300 IU of hp-hMG during the first week of ovarian stimulation. In both groups, if necessary, a daily injection of 300 Ill of hp-hMG was dispensed until the criteria for hCG administration are met. For the primary and secondary outcomes, results were analysed by using a one-sided chi-square test or a Fisher exact test, as appropriate, with a level of significance of 0.05. For continuous variables, parametric (independent t-test) or non-parametric (Mann-Whitney test) tests were used depending on the normality of the distribution. Statistical significance was set at P < 0.05. Results: The ongoing pregnancy rate, live birth rate (15.2 vs 20.2) (P = 0.33), and the cumulative live birth rate (15.2 vs 22.0) (P = 0.19) per started cycle did not show significant differences between the corifollitropin alfa and hp-hMG groups, and the difference estimated between treatments was -5% [95% CI: (-15.1, 5.0)]. Conclusions: It was not possible to probe non-inferiority of the protocol with corifollitropin alfa followed by hp-hMG compared to hp-hMG in patients at risk of poor ovarian response undergoing ICSI. (C) 2018 Elsevier B.V. All rights reserved.

Dades de la publicació

ISSN/ISSNe:: 0301-2115, 1872-7654
Tipus:: Article
Pàgines:: 192-197
DOI:: 10.1016/j.ejogrb.2018.10.034
PubMed:: 30428403
Factor d'Impacte:: 0,840 SCImago ℠
Quartil:: Q2 SCImago ℠

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Mètriques

Filiacions

Taronger, R:: Univ & Polytech Hosp La Fe, Dept Obstet & Gynaecol, Reprod Unit, Avda Fernando Abril Martorell 106, Valencia 46026, Spain

Instituto de Investigación. Hlth Res Inst La Fe IIS La Fe, Valencia, Spain

Instituto de Investigación. SCReN IIS La Fe, Spanish Clin Res Network, P117-0017-0035, Valencia, Spain
Martinez-Cuenca, S:: Univ & Polytech Hosp La Fe, Dept Obstet & Gynaecol, Reprod Unit, Avda Fernando Abril Martorell 106, Valencia 46026, Spain

Instituto de Investigación. Hlth Res Inst La Fe IIS La Fe, Valencia, Spain

Instituto de Investigación. SCReN IIS La Fe, Spanish Clin Res Network, P117-0017-0035, Valencia, Spain
Ferreros, I:: IVI Fdn, IVI RMA, Valencia, Spain
Rubio, JM:: Univ & Polytech Hosp La Fe, Dept Obstet & Gynaecol, Reprod Unit, Avda Fernando Abril Martorell 106, Valencia 46026, Spain

Instituto de Investigación. Hlth Res Inst La Fe IIS La Fe, Valencia, Spain

Instituto de Investigación. SCReN IIS La Fe, Spanish Clin Res Network, P117-0017-0035, Valencia, Spain
Fernandez-Colom, PJ:: Univ & Polytech Hosp La Fe, Dept Obstet & Gynaecol, Reprod Unit, Avda Fernando Abril Martorell 106, Valencia 46026, Spain

Instituto de Investigación. Hlth Res Inst La Fe IIS La Fe, Valencia, Spain

Instituto de Investigación. SCReN IIS La Fe, Spanish Clin Res Network, P117-0017-0035, Valencia, Spain
Martinez-Triguero, ML:: Univ & Polytech Hosp La Fe, Dept Clin Anal, Valencia, Spain
Pellicer, A:: Univ & Polytech Hosp La Fe, Dept Obstet & Gynaecol, Reprod Unit, Avda Fernando Abril Martorell 106, Valencia 46026, Spain

Instituto de Investigación. Hlth Res Inst La Fe IIS La Fe, Valencia, Spain

Instituto de Investigación. SCReN IIS La Fe, Spanish Clin Res Network, P117-0017-0035, Valencia, Spain

IVI RMA, Valencia, Spain

Univ Valencia, Dept Paediat Obstet & Gynaecol, Sch Med, Valencia, Spain