TY - JOUR
T1 - Hysteroscopy before in-vitro fertilisation (inSIGHT)
T2 - a multicentre, randomised controlled trial
AU - Smit, Janine G.
AU - Kasius, Jenneke C.
AU - Eijkemans, Marinus J. C.
AU - Koks, Carolien A. M.
AU - van Golde, Ron
AU - Nap, Annemiek W.
AU - Scheffer, Gabrielle J.
AU - Manger, Petra A. P.
AU - Hoek, Annemieke
AU - Schoot, Benedictus C.
AU - van Heusden, Arne M.
AU - Kuchenbecker, Walter K. H.
AU - Perquin, Denise A. M.
AU - Fleischer, Kathrin
AU - Kaaijk, Eugenie M.
AU - Sluijmer, Alexander
AU - Friederich, Jaap
AU - Dykgraaf, Ramon H. M.
AU - van Hooff, Marcel
AU - Louwe, Leonie A.
AU - Kwee, Janet
AU - de Koning, Corry H.
AU - Janssen, Ineke C. A. H.
AU - Mol, Femke
AU - Mol, Ben W. J.
AU - Broekmans, Frank J. M.
AU - Torrance, Helen L.
PY - 2016/6/25
Y1 - 2016/6/25
N2 - 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 (
AB - 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 (
U2 - 10.1016/S0140-6736(16)00231-2
DO - 10.1016/S0140-6736(16)00231-2
M3 - Article
SN - 0140-6736
VL - 387
SP - 2622
EP - 2629
JO - Lancet
JF - Lancet
IS - 10038
ER -