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

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 & 7 others Janet Kwee, Corry H. de Koning, Ineke C A H Janssen, Femke Mol, Ben W J Mol, Frank J M Broekmans, Helen L. Torrance

Research output: Contribution to journalArticle

26 Citations (Scopus)

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).

LanguageEnglish
Pages2622-2629
Number of pages8
JournalThe Lancet
Volume387
Issue number10038
DOIs
Publication statusPublished - 25 Jun 2016

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Smit, J. G., Kasius, J. C., Eijkemans, M. J. C., Koks, C. A. M., van Golde, R., Nap, A. W., ... Torrance, H. L. (2016). Hysteroscopy before in-vitro fertilisation (inSIGHT): a multicentre, randomised controlled trial. The Lancet, 387(10038), 2622-2629. https://doi.org/10.1016/S0140-6736(16)00231-2
Smit, Janine G. ; Kasius, Jenneke C. ; Eijkemans, Marinus J C ; Koks, Carolien A M ; van Golde, Ronald ; Nap, Annemiek W. ; Scheffer, Gabrielle J. ; Manger, Petra A P ; Hoek, Annemieke ; Schoot, Benedictus C. ; van Heusden, Arne M. ; Kuchenbecker, Walter K H ; Perquin, Denise A M ; Fleischer, Kathrin ; Kaaijk, Eugenie M. ; Sluijmer, Alexander ; Friederich, Jaap ; Dykgraaf, Ramon H M ; van Hooff, Marcel ; Louwe, Leonie A. ; Kwee, Janet ; de Koning, Corry H. ; Janssen, Ineke C A H ; Mol, Femke ; Mol, Ben W J ; Broekmans, Frank J M ; Torrance, Helen L. / Hysteroscopy before in-vitro fertilisation (inSIGHT) : a multicentre, randomised controlled trial. In: The Lancet. 2016 ; Vol. 387, No. 10038. pp. 2622-2629.
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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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Smit, JG, Kasius, JC, Eijkemans, MJC, Koks, CAM, van Golde, R, Nap, AW, Scheffer, GJ, Manger, PAP, Hoek, A, Schoot, BC, van Heusden, AM, Kuchenbecker, WKH, Perquin, DAM, Fleischer, K, Kaaijk, EM, Sluijmer, A, Friederich, J, Dykgraaf, RHM, van Hooff, M, Louwe, LA, Kwee, J, de Koning, CH, Janssen, ICAH, Mol, F, Mol, BWJ, Broekmans, FJM & Torrance, HL 2016, 'Hysteroscopy before in-vitro fertilisation (inSIGHT): a multicentre, randomised controlled trial', The Lancet, vol. 387, no. 10038, pp. 2622-2629. https://doi.org/10.1016/S0140-6736(16)00231-2

Hysteroscopy before in-vitro fertilisation (inSIGHT) : a multicentre, randomised controlled trial. / Smit, Janine G.; Kasius, Jenneke C.; Eijkemans, Marinus J C; Koks, Carolien A M; van Golde, Ronald; Nap, Annemiek W.; Scheffer, Gabrielle J.; Manger, Petra A P; Hoek, Annemieke; Schoot, Benedictus C.; van Heusden, Arne M.; Kuchenbecker, Walter K H; Perquin, Denise A M; Fleischer, Kathrin; Kaaijk, Eugenie M.; Sluijmer, Alexander; Friederich, Jaap; Dykgraaf, Ramon H M; van Hooff, Marcel; Louwe, Leonie A.; Kwee, Janet; de Koning, Corry H.; Janssen, Ineke C A H; Mol, Femke; Mol, Ben W J; Broekmans, Frank J M; Torrance, Helen L.

In: The Lancet, Vol. 387, No. 10038, 25.06.2016, p. 2622-2629.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Hysteroscopy before in-vitro fertilisation (inSIGHT)

T2 - Lancet

AU - Smit, Janine G.

AU - Kasius, Jenneke C.

AU - Eijkemans, Marinus J C

AU - Koks, Carolien A M

AU - van Golde, Ronald

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 (<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).

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 (<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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DO - 10.1016/S0140-6736(16)00231-2

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JO - Lancet

JF - Lancet

SN - 0140-6736

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Smit JG, Kasius JC, Eijkemans MJC, Koks CAM, van Golde R, Nap AW et al. Hysteroscopy before in-vitro fertilisation (inSIGHT): a multicentre, randomised controlled trial. The Lancet. 2016 Jun 25;387(10038):2622-2629. https://doi.org/10.1016/S0140-6736(16)00231-2