56 Chapter 3 SUPPLEMENTARY MATERIAL Supplementary Table 1. Trial Registration Data Acronym H2Olie2 Title H2Oil2: Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial Scientific title Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial Summary Rationale: We hypothesize that tubal flushing at hysterosalpingography (HSG) with oil-based contrast will result in higher pregnancy and live birth rates as compared to tubal flushing at HSG with water-based contrast in women: with an ovulation disorder, at high risk for tubal pathology and/or ≥38 years of age, which will lead to a reduction in the need for expensive fertility treatments like IVF and/ or ICSI, and will therefore be a cost effective strategy. Objective: The objective of the proposed study is to assess the effectiveness and costeffectiveness of the use of oil versus water-based contrast medium in terms of live birth in women undergoing HSG, who: 1: have ovulation disorders and/or; 2: are at high risk for tubal pathology and/or; 3: are 39 years of age or over. Study design: Multicenter, randomized controlled trial with a cost-effectiveness analysis alongside it. Study population: We will study women: 1: with ovulation disorders and/or; 2: at high risk for tubal pathology and/or; 3: are 39 years of age or over. Intervention: We will compare tubal flushing at HSG with oil-based contrast (intervention) versus tubal flushing with water-based contrast (control). Main study parameters/ endpoints: The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization. We will also study time-to-pregnancy. Our hypothesis is that HSG with oil-based contrast will increase pregnancy. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As we compare strategies (HSG with oil-based contrast versus HSG with waterbased contrast) that are already applied in current practice, no additional risks or burdens are expected from the study. Status Open for patient inclusion Control group Active Grouping Parallel Arms 2 or more arms, randomized Masking None Target size 930 Inclusion criteria In order to be eligible to participate in this study, women must meet one of the following criteria: 1: with ovulation disorders (ovulation disorders will be defined as less than 8 menstrual cycles per year) or; 2: at high risk for tubal pathology (high risk for tubal pathology will be defined as a positive chlamydia infection, a pelvic inflammatory disease, known endometriosis, abdominal surgery (including tubectomy for ectopic pregnancy and appendectomy) and/or peritonitis in the medical history) or; 3: 39 years of age or over
RkJQdWJsaXNoZXIy MTk4NDMw