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Randomized Controlled Trial
. 2016 Jun 25;387(10038):2622-2629.
doi: 10.1016/S0140-6736(16)00231-2. Epub 2016 Apr 27.

Hysteroscopy before in-vitro fertilisation (inSIGHT): a multicentre, randomised controlled trial

Janine G Smit  1 , Jenneke C Kasius  2 , Marinus J C Eijkemans  3 , Carolien A M Koks  4 , Ronald van Golde  5 , Annemiek W Nap  6 , Gabrielle J Scheffer  7 , Petra A P Manger  8 , Annemieke Hoek  9 , Benedictus C Schoot  10 , Arne M van Heusden  11 , Walter K H Kuchenbecker  12 , Denise A M Perquin  13 , Kathrin Fleischer  14 , Eugenie M Kaaijk  15 , Alexander Sluijmer  16 , Jaap Friederich  17 , Ramon H M Dykgraaf  18 , Marcel van Hooff  19 , Leonie A Louwe  20 , Janet Kwee  21 , Corry H de Koning  22 , Ineke C A H Janssen  23 , Femke Mol  24 , Ben W J Mol  25 , Frank J M Broekmans  2 , Helen L Torrance  2
Affiliations
Randomized Controlled Trial

Hysteroscopy before in-vitro fertilisation (inSIGHT): a multicentre, randomised controlled trial

Janine G Smit et al. Lancet. .

Erratum in

  • Department of Error.
    [No authors listed] [No authors listed] Lancet. 2019 Jun 15;393(10189):2394. doi: 10.1016/S0140-6736(19)31059-1. Lancet. 2019. PMID: 31204680 No abstract available.

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.

Findings: 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.

Interpretation: 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.

Funding: The Dutch Organisation for Health Research and Development (ZonMW).

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