The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial

Multicenter randomised controlled trial in asymptomatic subfertile women, indicated for a first IVF/ICSI treatment cycle, with normal findings at transvaginal sonography. Women with recurrent miscarriages, prior hysteroscopy treatment and intermenstrual blood loss will not be included. Participants will be randomised for a routine fertility work-up with additional (SIS and) hysteroscopy with on-the-spot-treatment of predefined intrauterine abnormalities versus the regular fertility work-up without additional diagnostic tests. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation. Secondary study outcome parameters are the cumulative implantation rate; cumulative miscarriage rate; patient preference and patient tolerance of a SIS and hysteroscopy procedure. All data will be analysed according to the intention-to-treat principle, using univariate and multivariate logistic regression and cox regression. Cost-effectiveness analysis will be performed to evaluate the costs of the additional tests as routine procedure. In total 700 patients will be included in this study.The results of this study will help to clarify the significance of hysteroscopy prior to IVF treatment.NCT01242852Despite the numerous advances in the field of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), the maximum implantation rate per embryo transferred is still approximately 30%. Even if both ovum pick-up and fertilization occur successfully in the process of IVF, there is a large unexplained gap between successful embryo transfer and occurrence of pregnancy. Implantation failure presents a major clinical challenge and is a cause of considerable stress to patients and clinicians in assisted reproductive technology (ART). Besides the psychological and physical burden of each IVF treatment cycle, it also adds to the considerable costs associated with fertility treatment [