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Hum. Reprod. Advance Access published online on May 12, 2005
Human Reproduction, doi:10.1093/humrep/deh818
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© The Author 2005. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org
Received November 7, 2004
Revised January 27, 2005
Accepted January 28, 2005

Review

Resolving methodological and clinical issues in the design of efficacy trials in assisted reproductive technologies: a mini-review

J.-C. Arce 1, A. Nyboe Andersen 2, and J. Collins 3*

1 Ferring Pharmaceuticals A/S, Clinical Research and Development, Copenhagen, Denmark
2 The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark and
3 McMaster University, Hamilton, Canada

* To whom correspondence should be addressed.
J. Collins, E-mail: collinsj{at}aura.com


  Abstract

The validity, importance and relevance of randomized controlled trials depend on identifying an appropriate target population, ensuring adequate power, careful attention to the details of randomization and blinding, and selection of an endpoint that is important to the target population. With efficacy trials more than effectiveness trials, additional constraints are needed to reduce the variability that is typical of clinical practice: a narrowly defined sample, unvarying pre-randomization procedures and post-randomization treatments and follow-up that are as identical as possible for all patients. Efficacy trials comparing ovarian stimulation protocols should have strict protocol definitions, specific concomitant medications and minimal variability between centres with respect to stimulation goals and dose adjustments. Additionally, there should be narrowly defined criteria for administration of chorionic gonadotrophin, type of luteal support, embryo transfer and freezing policies. The goal of efficacy trials is to minimize the variability that is extrinsic to the comparison. When efficacy has been proven, effectiveness trials are needed to determine whether the effect of the new intervention is robust in the variability of typical clinical settings.


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