Table 1 Outcomes and descriptions

Primary outcome

Definition/measurement

Time to conception leading to live birth measured at 6 months

Calculated from the first day of the last menstrual bleeding before a positive pregnancy test

Time to conception leading to live birth measured at 12 months

Calculated from the first day of the last menstrual bleeding before a positive pregnancy test

Secondary outcome

Definition/measurement

Biochemical pregnancy

A positive pregnancy test or serum HCG-level greater than 5 IU/L

Clinical pregnancy

Gestational sac visible on ultrasonography

Ongoing pregnancy

Positive heartbeat at 12 weeks of pregnancy on ultrasonography

Miscarriage

Non-vitality on ultrasound or spontaneous loss of pregnancy

Ectopic pregnancy

No intrauterine gestational sac with an ectopic gestational sac and/or persistent serum HCG levels

Multiple pregnancy

Pregnancy of two or more fetuses

Complications after HSG

All adverse events occurring within one month after HSG procedure, for example pelvic infection, intravasation and allergic reaction

Level of pain during HSG

Reported on VAS (scores: 0.0 to 10.0 cm)

Thyroid function after HSG

Serum FT4 and TSH one month after HSG

Used fertility treatments

IUI, IVF, ICSI

Pregnancy complications

E.g. pregnancy induced hypertension, gestational diabetes, still birth

Pregnancy outcomes

E.g. gestational age, pre-term birth, birth weight

Cost-effectiveness

Effectiveness: time to conception leading to live birth

Costs:

Healthcare perspective: costs for HSG and fertility treatments

Societal perspective: healthcare costs, loss of productivity costs and patient costs (care services paid for by the patients themselves) using iMCQ and iPCQ