Large comparative randomized double blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle stimulating hormone in a gonadotropin releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization

Capsule:
A single injection of corifollitropin alfa for the first 7 days of controlled ovarian stimulation was as effective as daily recombinant FSH in older IVF patients, and was generally well tolerated.

Authors:
Robert Boostanfar, M.D., Bruce Shapiro, Ph.D., M.D., Michael Levy, M.D., Zev Rosenwaks, M.D., Han Witjes, Ph.D., Barbara J. Stegmann, M.D., Jolanda Elbers, Ph.D., Keith Gordon, Ph.D., Bernadette Mannaerts, Ph.D. for the Pursue investigators

Volume 104, Issue 1, Pages 94–103

Abstract:

Objective:
To compare corifollitropin alfa with recombinant FSH treatment in terms of the vital pregnancy rate in older patients undergoing IVF.

Design:
Phase 3 randomized, double-blind, noninferiority trial.

Setting:
Multicenter trial.

Patient(s):
A total of 1,390 women aged 35–42 years.

Intervention(s):
A single injection of 150 μg of corifollitropin alfa or daily 300 IU of recombinant FSH for the first 7 days then daily recombinant FSH until three follicles reach ≥17 mm in size. Ganirelix was started on stimulation day 5 up to and including the day of recombinant hCG administration. If available, two good quality embryos were transferred on day 3.

Main Outcome Measure(s):
Vital pregnancy rate (PR), number of oocytes, and live birth rate.

Result(s):
Vital PRs per started cycle were 23.9% in the corifollitropin alfa group and 26.9% in the recombinant FSH group, with an estimated difference (95% confidence interval) of -3.0% (−7.4 to 1.4). The mean (SD) number of recovered oocytes per started cycle was 10.7 (7.2) and 10.3 (6.8) in the corifollitropin alfa and the recombinant FSH groups, respectively, with an estimated difference of 0.5 (−0.2 to 1.2). The live birth rates per started cycle were 21.3% in the corifollitropin alfa group and 23.4% in the recombinant FSH group, with an estimated difference (95% confidence interval) −2.3% (−6.5 to 1.9). The incidence of serious adverse events was 0.4% versus 2.7% in the corifollitropin alfa and recombinant FSH groups, respectively, and of ovarian hyperstimulation syndrome (OHSS; all grades) was 1.7% in both groups.

Conclusion(s):
Treatment with corifollitropin alfa was proven noninferior to daily recombinant FSH with respect to vital PRs, number of oocytes retrieved, and live birth rates, and was generally well tolerated.

Clinical Trial Registration Number:
NCT01144416.

  • Amanda N. Kallen

    Thanks to the authors for this very interesting study! I do have two questions for the authors. First, since the trial was conducted between 2010 and 2012, do you have any data (or plans to look at data) on subsequent live birth rates in this study population? And second, as the generalizability of the study is limited (due to exclusion of anovulatory / PCOS women) are there any plans to conduct future studies with a broader patient population?

Translate »