Table 1. SPIRIT figure including all study activities.
Study period | ||||||
Enrolment | Allocation | Post-allocation | ||||
Timepoint | t-1 | 0 | t1 | t2 | t3 | t4 |
Enrolment | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Allocation | X | |||||
Interventions | ||||||
HSG with oil-based contrast | X | |||||
HyFoSy with ExEm Foam | X | |||||
Assessments | ||||||
Demographics | X | |||||
Thyroid function testing* | X | X | ||||
APAIS | X | |||||
Pain score (VAS) | X | |||||
Procedure and results | X | |||||
Adverse events | X | X | ||||
iMCQ and iPCQ | X | |||||
Treatments | X | |||||
Pregnancies | X | |||||
Pregnancy follow-up | X |
t−-1: prior to allocation, t1: day of intervention, t2: one1 month after tubal patency testing, t3: 6 months after randomizsation, t4: after giving birth.
nNo mandatory study intervention.
APAIS, Amsterdam Preoperative Anxiety and Information Scale; iMCQ, Medical Consumption Questionnaire; iPCQ, Productivity Cost QuestionnaireSPIRITStandard Protocol Items: Recommendations For Interventional TrialsVAS, Visual Analog Scale