title: Hysteroscopy before in-vitro fertilisation (inSIGHT): a multicentre, randomised controlled trial.
abstract: BACKGROUND
  Hysteroscopy is often done in infertile women starting in-vitro fertilisation (IVF) to improve their chance of having a baby. However, no data are available from randomised controlled trials to support this practice. We aimed to assess whether routine hysteroscopy before the first IVF treatment cycle increases the rate of livebirths.
  
  
  METHODS
  We did a pragmatic, multicentre, randomised controlled trial in seven university hospitals and 15 large general hospitals in the Netherlands. Women with a normal transvaginal ultrasound of the uterine cavity and no previous hysteroscopy who were scheduled for their first IVF treatment were randomly assigned (1:1) to either hysteroscopy with treatment of detected intracavitary abnormalities before starting IVF (hysteroscopy group) or immediate start of the IVF treatment (immediate IVF group). Randomisation was done with web-based concealed allocation and was stratified by centre with variable block sizes. Participants, doctors, and outcome assessors were not masked to the assigned group. The primary outcome was ongoing pregnancy (detection of a fetal heartbeat at >12 weeks of gestation) within 18 months of randomisation and resulting in livebirth. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01242852.
  
  
  RESULTS
  Between May 25, 2011, and Aug 27, 2013, we randomly assigned 750 women to receive either hysteroscopy (n=373) or immediate IVF (n=377). 209 (57%) of 369 women eligible for assessment in the hysteroscopy group and 200 (54%) of 373 in the immediate IVF group had a livebirth from a pregnancy during the trial period (relative risk 1·06, 95% CI 0·93-1·20; p=0·41). One (<1%) woman in the hysteroscopy group developed endometritis after hysteroscopy.
  
  
  CONCLUSIONS
  Routine hysteroscopy does not improve livebirth rates in infertile women with a normal transvaginal ultrasound of the uterine cavity scheduled for a first IVF treatment. Women with a normal transvaginal ultrasound should not be offered routine hysteroscopy.
  
  
  BACKGROUND
  The Dutch Organisation for Health Research and Development (ZonMW).
authors.affiliation: Department of Reproductive Medicine and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands. Electronic address: jsmit9@umcutrecht.nl.
authors.forename: Janine G
authors.initials: JG
authors.lastname: Smit
authors.affiliation: Department of Reproductive Medicine and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Jenneke C
authors.initials: JC
authors.lastname: Kasius
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Marinus J C
authors.initials: MJC
authors.lastname: Eijkemans
authors.affiliation: Maxima Medical Center, Veldhoven, Netherlands.
authors.forename: Carolien A M
authors.initials: CAM
authors.lastname: Koks
authors.affiliation: Maastricht University Medical Center, Maastricht, Netherlands.
authors.forename: Ronald
authors.initials: R
authors.lastname: van Golde
authors.affiliation: Rijnstate Hospital, Arnhem, Netherlands.
authors.forename: Annemiek W
authors.initials: AW
authors.lastname: Nap
authors.affiliation: Gelre Hospital, Apeldoorn, Netherlands.
authors.forename: Gabrielle J
authors.initials: GJ
authors.lastname: Scheffer
authors.affiliation: Diakonessen Hospital Utrecht, Utrecht, Netherlands.
authors.forename: Petra A P
authors.initials: PAP
authors.lastname: Manger
authors.affiliation: University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
authors.forename: Annemieke
authors.initials: A
authors.lastname: Hoek
authors.affiliation: Catharina Hospital, Eindhoven, Netherlands.
authors.forename: Benedictus C
authors.initials: BC
authors.lastname: Schoot
authors.affiliation: Antonius Hospital, Nieuwegein, Netherlands.
authors.forename: Arne M
authors.initials: AM
authors.lastname: van Heusden
authors.affiliation: Isala, Zwolle, Netherlands.
authors.forename: Walter K H
authors.initials: WKH
authors.lastname: Kuchenbecker
authors.affiliation: Medical Center Leeuwarden, Leeuwarden, Netherlands.
authors.forename: Denise A M
authors.initials: DAM
authors.lastname: Perquin
authors.affiliation: University Medical Center St Radboud, Nijmegen, Netherlands.
authors.forename: Kathrin
authors.initials: K
authors.lastname: Fleischer
authors.affiliation: Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.
authors.forename: Eugenie M
authors.initials: EM
authors.lastname: Kaaijk
authors.affiliation: Wilhelmina Hospital, Assen, Netherlands.
authors.forename: Alexander
authors.initials: A
authors.lastname: Sluijmer
authors.affiliation: Gemini Hospital, Den Helder, Netherlands.
authors.forename: Jaap
authors.initials: J
authors.lastname: Friederich
authors.affiliation: Erasmus MC, Rotterdam, Netherlands.
authors.forename: Ramon H M
authors.initials: RHM
authors.lastname: Dykgraaf
authors.affiliation: Sint Franciscus Gasthuis, Rotterdam, Netherlands.
authors.forename: Marcel
authors.initials: M
authors.lastname: van Hooff
authors.affiliation: Leids University Medical Center, University of Leiden, Leiden, Netherlands.
authors.forename: Leonie A
authors.initials: LA
authors.lastname: Louwe
authors.affiliation: Sint Lucas Andreas Hospital, Amsterdam, Netherlands.
authors.forename: Janet
authors.initials: J
authors.lastname: Kwee
authors.affiliation: Tergooi Hospitals, Blaricum, Netherlands.
authors.forename: Corry H
authors.initials: CH
authors.lastname: de Koning
authors.affiliation: Groene Hart Hospital, Gouda, Netherlands.
authors.forename: Ineke C A H
authors.initials: ICAH
authors.lastname: Janssen
authors.affiliation: Center for Reproductive Medicine, Academic Medical Center, Amsterdam, Netherlands.
authors.forename: Femke
authors.initials: F
authors.lastname: Mol
authors.affiliation: The Robinson Institute, School of Paediatrics and Reproductive Health, Adelaide, SA, Australia; The South Australian Health and Medical Research Institute, Adelaide, SA, Australia.
authors.forename: Ben W J
authors.initials: BWJ
authors.lastname: Mol
authors.affiliation: Department of Reproductive Medicine and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Frank J M
authors.initials: FJM
authors.lastname: Broekmans
authors.affiliation: Department of Reproductive Medicine and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Helen L
authors.initials: HL
authors.lastname: Torrance
mesh_terms: D000328:Adult; D000556:Ambulatory Surgical Procedures; D005260:Female; D005307:Fertilization in Vitro; D006801:Humans; D015907:Hysteroscopy; D007247:Infertility, Female / Q000628:therapy*; D050498:Live Birth; D009426:Netherlands; D011247:Pregnancy; D013997:Time Factors; D016896:Treatment Outcome