Crossover or parallel design in infertility trials? The discussion continues

Fertility and Sterility
B J CohlenJ D Habbema

Abstract

To determine whether a crossover design results in a different estimate of treatment effect compared with a parallel design. With the aid of a computer program, data sets of subfertile patients were simulated under different assumptions. These patients were subjected to 2 treatments that were compared in either a parallel-design or a crossover-design trial. Results were analyzed using logistic regression. University hospital. Simulated patients of a heterogeneous subfertile population. Two treatment modalities with a pregnancy rate of 10% and of 20% in the first cycle were offered for 6 cycles to simulated heterogeneous populations. After 1,000 simulations for each assumption, median pregnancy rates and odds ratios were compared between the crossover- and parallel-design trials. No relevant difference in estimated treatment effect was found between the designs. The crossover design resulted in more pregnancies overall than the parallel design. In infertility research, parallel and crossover designs will lead to about the same results. Although the crossover design showed a slight tendency to overestimate the treatment effect of the most effective treatment, this overestimation is clinically not relevant and is small in relation...Continue Reading

References

Nov 1, 1975·Demography·J Bongaarts
Apr 1, 1989·Annals of Internal Medicine·J R WoodsM Tavel
Nov 1, 1993·British Journal of Obstetrics and Gynaecology·P VandekerckhoveT W Harada
Mar 13, 1998·Fertility and Sterility·E R te VeldeJ D Habbema

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Citations

Dec 21, 2010·Statistics in Medicine·Boikanyo Makubate, Stephen Senn
Apr 20, 2004·The Australian & New Zealand Journal of Obstetrics & Gynaecology·Michael F Costello
Mar 27, 2002·International Journal of Epidemiology·Diana R ElbourneAndy Vail
Mar 4, 2020·The Cochrane Database of Systematic Reviews·Reuben Olugbenga AyelekeSusanne M Veltman-Verhulst
Oct 2, 2004·Human Reproduction·Joseph McDonnellJan P W Vermeiden
Feb 27, 2016·The Cochrane Database of Systematic Reviews·Maartje CissenMadelon van Wely
Aug 2, 2019·BMJ : British Medical Journal·Kerry DwanDiana Elbourne
Feb 20, 2016·The Cochrane Database of Systematic Reviews·Susanne M Veltman-VerhulstBen J Cohlen
Jul 15, 2003·Gynecological Endocrinology : the Official Journal of the International Society of Gynecological Endocrinology·P FedorcsákT Tanbo

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