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Eur J Obstet Gynecol Reprod Biol. 2018 Dec;231:192-197. doi: 10.1016/j.ejogrb.2018.10.034. Epub 2018 Oct 13.

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.

Author information

1
Department of Obstetrics and Gynaecology, Reproduction Unit, University and Polytechnic Hospital La Fe, Valencia, Spain; The Health Research Institute La Fe (IIS La Fe), Valencia, Spain; Spanish Clinical Research Network, SCReN-IIS La Fe, PT17/0017/0035, Valencia, Spain. Electronic address: rtaroncherd@sego.es.
2
Department of Obstetrics and Gynaecology, Reproduction Unit, University and Polytechnic Hospital La Fe, Valencia, Spain; The Health Research Institute La Fe (IIS La Fe), Valencia, Spain; Spanish Clinical Research Network, SCReN-IIS La Fe, PT17/0017/0035, Valencia, Spain.
3
IVI-RMA, IVI Foundation, Valencia, Spain.
4
Department of Clinical Analysis, University and Polytechnic Hospital La Fe, Valencia, Spain.
5
Department of Obstetrics and Gynaecology, Reproduction Unit, University and Polytechnic Hospital La Fe, Valencia, Spain; The Health Research Institute La Fe (IIS La Fe), Valencia, Spain; Spanish Clinical Research Network, SCReN-IIS La Fe, PT17/0017/0035, Valencia, Spain; IVI-RMA, Valencia, Spain; Department of Paediatrics, Obstetrics and Gynaecology, School of Medicine, Valencia University, Spain.

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 μg 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 IU 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.

KEYWORDS:

Corifollitropin alfa; In vitro fertilization; Poor ovarian response; hp-hMG

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