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Since intention-to-treat analyses is more adequate for implementing the results of this study in daily fertility practice such an analyses will be performed also besides a per-protocol analysis.
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The level of significance for all analyses will be a priori established at 0.05 using a two-tailed test.
A priori and a posteriori analyses will be clearly labelled as such.
A secondary analyses will be conducted excluding patients with missing data.
If differences between TG and CG are revealed (for example concerning age), a covariance analyses will be proceeded.
To test the validity of the imputation, a sensitivity analyses will be performed restricting our cohort to patients without missing data (complete case analysis) [ 31].
A cost-effectiveness analyses will be performed from a social and a patient perspective, looking at differences in direct and indirect health care cost between the two groups.
To ensure factor structure of the SRI-G, an explanatory factor analyses will be conducted (principal component analyses, VARIMAX rotation) and the results will be compared to the source study.
A combined cost-effectiveness/cost-utility analyses will be performed from a societal perspective.
Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics.
Furthermore, a number of exploratory analyses will be performed.
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