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Methodological and clinical issues to be considered in the design of efficacy trials in assisted reproductive technologies

Wednesday, 3 June, 2009 - 17:00
Campus: Brussels Health Campus
Faculty: Medicine and Pharmacy
auditorium P. Brouwer
Joan-Carles Arce
phd defence

Scientific evidence derived from optimal trial
designs should guide decisions on treatment
strategies. Continuing efforts are needed to
identify methodological pitfalls in the design of
efficacy trials in ART. Areas for improvements
include well-defined study populations, stricter
protocols, harmonisation of the type and doses of
concomitant fertility medications, reduction of
variability arising from different centre protocols
for stimulation goals, dose adjustments, timing of
triggering final follicular maturation and luteal
phase support, as well as different procedures
and policies for embryo transfer and freezing.

The thesis provides a theoretical rationale for
considering more rigid designs for efficacy trials
in ART and has documented that it is feasible to
conduct a study applying these theoretical
methodological considerations into clinical
research practice. A specific trial was used to
illustrate the link between design decisions and
practical execution, and can be viewed as a step
forward in improving the design of efficacy trials
in ART and as a methodological reference point
for future trials. The approach used in this case
study comparing gonadotrophin preparations
could be extrapolated to many other areas of
interest in ART, and the concepts are applicable
to RCTs in general, covering both academiainitiated
clinical trials as well as larger scale
industry-based clinical research.