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

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

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.

Publication types

  • Comparative Study
  • Equivalence Trial

MeSH terms

  • Adult
  • Birth Rate
  • Female
  • Fertility Agents, Female / administration & dosage*
  • Follicle Stimulating Hormone, Human / administration & dosage*
  • Humans
  • Menotropins / administration & dosage*
  • Ovulation Induction / methods*
  • Pregnancy
  • Pregnancy Rate
  • Prospective Studies
  • Sperm Injections, Intracytoplasmic / methods*

Substances

  • Fertility Agents, Female
  • Follicle Stimulating Hormone, Human
  • follicle stimulating hormone, human, with HCG C-terminal peptide
  • Menotropins