title: The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial.
abstract: BACKGROUND
  In in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) treatment a large drop is present between embryo transfer and occurrence of pregnancy. The implantation rate per embryo transferred is only 30%. Studies have shown that minor intrauterine abnormalities can be found in 11-45% of infertile women with a normal transvaginal sonography or hysterosalpingography. Two randomised controlled trials have indicated that detection and treatment of these abnormalities by office hysteroscopy after two failed IVF cycles leads to a 9-13% increase in pregnancy rate. Therefore, screening of all infertile women for intracavitary pathology prior to the start of IVF/ICSI is increasingly advocated. In absence of a scientific basis for such a policy, this study will assess the effects and costs of screening for and treatment of unsuspected intrauterine abnormalities by routine office hysteroscopy, with or without saline infusion sonography (SIS), prior to a first IVF/ICSI cycle.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  The results of this study will help to clarify the significance of hysteroscopy prior to IVF treatment.
  
  
  BACKGROUND
  NCT01242852.
authors.affiliation: Department of Reproductive Medicine and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands. jsmit6@umcutrecht.nl
authors.forename: Janine G
authors.initials: JG
authors.lastname: Smit
authors.forename: Jenneke C
authors.initials: JC
authors.lastname: Kasius
authors.forename: Marinus J C
authors.initials: MJ
authors.lastname: Eijkemans
authors.forename: Carolien A M
authors.initials: CA
authors.lastname: Koks
authors.forename: Ron
authors.initials: R
authors.lastname: Van Golde
authors.forename: Jurjen G E
authors.initials: JG
authors.lastname: Oosterhuis
authors.forename: Annemiek W
authors.initials: AW
authors.lastname: Nap
authors.forename: Gabrielle J
authors.initials: GJ
authors.lastname: Scheffer
authors.forename: Petra A P
authors.initials: PA
authors.lastname: Manger
authors.forename: Annemiek
authors.initials: A
authors.lastname: Hoek
authors.forename: Mesrure
authors.initials: M
authors.lastname: Kaplan
authors.forename: Dick B C
authors.initials: DB
authors.lastname: Schoot
authors.forename: Arne M
authors.initials: AM
authors.lastname: van Heusden
authors.forename: Walter K H
authors.initials: WK
authors.lastname: Kuchenbecker
authors.forename: Denise A M
authors.initials: DA
authors.lastname: Perquin
authors.forename: Kathrin
authors.initials: K
authors.lastname: Fleischer
authors.forename: Eugenie M
authors.initials: EM
authors.lastname: Kaaijk
authors.forename: Alexander
authors.initials: A
authors.lastname: Sluijmer
authors.forename: Jaap
authors.initials: J
authors.lastname: Friederich
authors.forename: Joop S E
authors.initials: JS
authors.lastname: Laven
authors.forename: Marcel
authors.initials: M
authors.lastname: van Hooff
authors.forename: Leonie A
authors.initials: LA
authors.lastname: Louwe
authors.forename: Janet
authors.initials: J
authors.lastname: Kwee
authors.forename: Jantien J
authors.initials: JJ
authors.lastname: Boomgaard
authors.forename: Corry H
authors.initials: CH
authors.lastname: de Koning
authors.forename: Ineke C A H
authors.initials: IC
authors.lastname: Janssen
authors.forename: Femke
authors.initials: F
authors.lastname: Mol
authors.forename: Ben W J
authors.initials: BW
authors.lastname: Mol
authors.forename: Helen L
authors.initials: HL
authors.lastname: Torrance
authors.forename: Frank J M
authors.initials: FJ
authors.lastname: Broekmans
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005260:Female; D005307:Fertilization in Vitro; D006801:Humans; D015907:Hysteroscopy / Q000191:economics; D007247:Infertility, Female / Q000000981:diagnostic imaging / Q000191:economics / Q000209:etiology / Q000628:therapy*; D057194:Intention to Treat Analysis; D016015:Logistic Models; D015999:Multivariate Analysis; D009426:Netherlands; D057240:Patient Preference; D011247:Pregnancy; D018873:Pregnancy Rate; D016016:Proportional Hazards Models; D016037:Single-Blind Method; D020554:Sperm Injections, Intracytoplasmic; D016896:Treatment Outcome; D014463:Ultrasonography; D014591:Uterine Diseases / Q000150:complications / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000191:economics; D014599:Uterus / Q000002:abnormalities* / Q000000981:diagnostic imaging