57 H2Oil2 study protocol 3 Supplementary Table 1. (Continued) Acronym H2Olie2 Exclusion criteria - Iodinated contrast agent allergy - Male subfertility defined as total motile sperm count < 3 x10^6 spermatozoa/ml - Not willing or able to sign the consent form Start date 2019-08-20 Stop date 2023-08-01 Disease Subfertility, tubal patency testing Hypothesis We hypothesize that tubal flushing at hysterosalpingography (HSG) with oilbased contrast will result in higher pregnancy and live birth rates as compared to tubal flushing at HSG with water-based contrast in the target population. Interventions HSG as tubal patency test with oil-based contrast versus HSG as tubal patency test with water-based contrast. Primary outcome Conception leading to live birth with a positive pregnancy test within 6 months after randomization. Secondary outcome - Biochemical pregnancy, clinical pregnancy, ongoin pregnancy - Miscarriage, ectopic pregnancy, multiple pregnancy - Time to pregnancy - Complications following HSG (infection, intravastion) - Pregnancy outcomes (f.e. birth weight) - Pregnancy complications - Stillbirth - Thyroid function of the woman (before and 1 month after HSG) - Neonatal outcomes - Additional fertility treatments (Intrauterine insemination, IVF, IVF/ICSI) - Costs within 6 months after randomization - Thyroid function of neonate (determined by heelprick) Sponsors Amsterdam UMC, VUmc Time points Follow-up 6 months after randomization MEC approved Yes Randomized Yes Plan to share IPD Undecided IPD plan description N/A Publications N/A Issueing body METc VUmc Source ID NL66079.029.18 Funding sources ZonMw, Guerbet Old NTR ID N/A Date registered 2019-08-01 URL www.H2Olie.nl
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