• Janine G Smit, Jenneke C Kasius, Marinus J C Eijkemans, Carolien A M Koks, Ronald van Golde, Annemiek W Nap, Gabrielle J Scheffer, Petra A P Manger, Annemieke Hoek, Benedictus C Schoot, Arne M van Heusden, Walter K H Kuchenbecker, Denise A M Perquin, Kathrin Fleischer, Eugenie M Kaaijk, Alexander Sluijmer, Jaap Friederich, Ramon H M Dykgraaf, Marcel van Hooff, Leonie A Louwe, Janet Kwee, Corry H de Koning, Ineke C A H Janssen, Femke Mol, Ben W J Mol, Frank J M Broekmans, and Helen L Torrance.
• Department of Reproductive Medicine and Gynaecology, University Medical Center Utrecht, Utrecht, Netherlands. Electronic address: jsmit9@umcutrecht.nl.
• Lancet. 2016 Jun 25; 387 (10038): 2622-9.

BackgroundHysteroscopy 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.MethodsWe 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.FindingsBetween 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.InterpretationRoutine 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.FundingThe Dutch Organisation for Health Research and Development (ZonMW).Copyright © 2016 Elsevier Ltd. All rights reserved.

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