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Table 1 The expected timeline flow for patients participating in the trial

From: Effect of a single-dose denosumab on semen quality in infertile men (the FITMI study): study protocol for a randomized controlled trial

  1. A SPIRIT figure showing the expected timeline for the participants. If the participant fulfills the eligibility criteria, he is invited to the day 1 visit. Here they will provide another semen sample, have a blood sample drawn, and finally receive a subcutaneous injection of either denosumab 60 mg or placebo. On day 80 and day 83, the participants deliver the final semen samples. This is the last physical visit, while they will receive an electronic questionnaire asking about pregnancies and adverse events 6 months later. If they have achieved pregnancy before day 180, there will be sent an additional electronic questionnaire on day 450 regarding pregnancy complications, birth complications as well as data on the child
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Trials

ISSN: 1745-6215