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With natural-cycle IUI there are no drugs, no invasive procedures – sperm is simply placed near the Fallopian tube at the start of ovulation.
No invasive procedures will be performed on human volunteers, using simulation models / manikins in these circumstances.
Since no invasive procedures were applied in the study, no Ethics Committee System approval was required by Danish law.
3.2 Ethical review The study included no invasive procedures and participation in the study was voluntary, with written consent being required.
For example, detection of miRNAs in urine and saliva may be preferable to serum or plasma as collection of these biofluids requires no invasive procedures.
The sublingual mucosa is commonly chosen as a region for clinical studies since no invasive procedures are necessary to access this part of the circulatory system (Boerma et al. 2005; De Backer et al. 2002, 2004; Trzeciak and Rivers 2005).
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As the study involved no invasive procedure, verbal informed consent was deemed sufficient.
However, the interaction between a dichotomized age variable (<65 vs. 65+) and a dichotomized procedure variable (<span class="lh">no invasive procedure vs. having an invasive procedure) suggested that invasive procedures were more beneficial among younger (<65) ACS patients.
No invasive procedure was done.
One could therefore argue that we did not use a reliable diagnostic tool since no invasive procedure had been conducted.
The intervention did not include any invasive procedures and no adverse events of the interventions were reported.
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