The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial

Janine G. Smit, Jenneke C. Kasius, Marinus J C Eijkemans, Carolien A M Koks, Ron Van Golde, Jurjen G E Oosterhuis, Annemiek W. Nap, Gabrielle J. Scheffer, Petra A P Manger, Annemiek Hoek, Mesrure Kaplan, Dick B C Schoot, Arne M. van Heusden, Walter K H Kuchenbecker, Denise A M Perquin, Kathrin Fleischer, Eugenie M. Kaaijk, Alexander Sluijmer, Jaap Friederich, Joop S E Laven & 10 others Marcel van Hooff, Leonie A. Louwe, Janet Kwee, Jantien J. Boomgaard, Corry H. de Koning, Ineke C A H Janssen, Femke Mol, Ben W J Mol, Helen L. Torrance, Frank J M Broekmans

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Background: In in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) treatment a large drop is present between embryo transfer and occurrence of pregnancy. The implantation rate per embryo transferred is only 30%. Studies have shown that minor intrauterine abnormalities can be found in 11-45% of infertile women with a normal transvaginal sonography or hysterosalpingography. Two randomised controlled trials have indicated that detection and treatment of these abnormalities by office hysteroscopy after two failed IVF cycles leads to a 9-13% increase in pregnancy rate. Therefore, screening of all infertile women for intracavitary pathology prior to the start of IVF/ICSI is increasingly advocated. In absence of a scientific basis for such a policy, this study will assess the effects and costs of screening for and treatment of unsuspected intrauterine abnormalities by routine office hysteroscopy, with or without saline infusion sonography (SIS), prior to a first IVF/ICSI cycle.Methods/design: Multicenter randomised controlled trial in asymptomatic subfertile women, indicated for a first IVF/ICSI treatment cycle, with normal findings at transvaginal sonography. Women with recurrent miscarriages, prior hysteroscopy treatment and intermenstrual blood loss will not be included. Participants will be randomised for a routine fertility work-up with additional (SIS and) hysteroscopy with on-the-spot-treatment of predefined intrauterine abnormalities versus the regular fertility work-up without additional diagnostic tests. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation. Secondary study outcome parameters are the cumulative implantation rate; cumulative miscarriage rate; patient preference and patient tolerance of a SIS and hysteroscopy procedure. All data will be analysed according to the intention-to-treat principle, using univariate and multivariate logistic regression and cox regression. Cost-effectiveness analysis will be performed to evaluate the costs of the additional tests as routine procedure. In total 700 patients will be included in this study.Discussion: The results of this study will help to clarify the significance of hysteroscopy prior to IVF treatment.Trial registration: NCT01242852.

LanguageEnglish
Article number22
JournalBMC Women's Health
Volume12
DOIs
Publication statusPublished - 8 Aug 2012

Keywords

  • Hysteroscopy
  • IVF
  • Subfertility

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynaecology

Cite this

Smit, J. G., Kasius, J. C., Eijkemans, M. J. C., Koks, C. A. M., Van Golde, R., Oosterhuis, J. G. E., ... Broekmans, F. J. M. (2012). The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial. BMC Women's Health, 12, [22]. https://doi.org/10.1186/1472-6874-12-22
Smit, Janine G. ; Kasius, Jenneke C. ; Eijkemans, Marinus J C ; Koks, Carolien A M ; Van Golde, Ron ; Oosterhuis, Jurjen G E ; Nap, Annemiek W. ; Scheffer, Gabrielle J. ; Manger, Petra A P ; Hoek, Annemiek ; Kaplan, Mesrure ; Schoot, Dick B C ; van Heusden, Arne M. ; Kuchenbecker, Walter K H ; Perquin, Denise A M ; Fleischer, Kathrin ; Kaaijk, Eugenie M. ; Sluijmer, Alexander ; Friederich, Jaap ; Laven, Joop S E ; van Hooff, Marcel ; Louwe, Leonie A. ; Kwee, Janet ; Boomgaard, Jantien J. ; de Koning, Corry H. ; Janssen, Ineke C A H ; Mol, Femke ; Mol, Ben W J ; Torrance, Helen L. ; Broekmans, Frank J M. / The inSIGHT study : costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial. In: BMC Women's Health. 2012 ; Vol. 12.
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abstract = "Background: In in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) treatment a large drop is present between embryo transfer and occurrence of pregnancy. The implantation rate per embryo transferred is only 30{\%}. Studies have shown that minor intrauterine abnormalities can be found in 11-45{\%} of infertile women with a normal transvaginal sonography or hysterosalpingography. Two randomised controlled trials have indicated that detection and treatment of these abnormalities by office hysteroscopy after two failed IVF cycles leads to a 9-13{\%} increase in pregnancy rate. Therefore, screening of all infertile women for intracavitary pathology prior to the start of IVF/ICSI is increasingly advocated. In absence of a scientific basis for such a policy, this study will assess the effects and costs of screening for and treatment of unsuspected intrauterine abnormalities by routine office hysteroscopy, with or without saline infusion sonography (SIS), prior to a first IVF/ICSI cycle.Methods/design: Multicenter randomised controlled trial in asymptomatic subfertile women, indicated for a first IVF/ICSI treatment cycle, with normal findings at transvaginal sonography. Women with recurrent miscarriages, prior hysteroscopy treatment and intermenstrual blood loss will not be included. Participants will be randomised for a routine fertility work-up with additional (SIS and) hysteroscopy with on-the-spot-treatment of predefined intrauterine abnormalities versus the regular fertility work-up without additional diagnostic tests. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation. Secondary study outcome parameters are the cumulative implantation rate; cumulative miscarriage rate; patient preference and patient tolerance of a SIS and hysteroscopy procedure. All data will be analysed according to the intention-to-treat principle, using univariate and multivariate logistic regression and cox regression. Cost-effectiveness analysis will be performed to evaluate the costs of the additional tests as routine procedure. In total 700 patients will be included in this study.Discussion: The results of this study will help to clarify the significance of hysteroscopy prior to IVF treatment.Trial registration: NCT01242852.",
keywords = "Hysteroscopy, IVF, Subfertility",
author = "Smit, {Janine G.} and Kasius, {Jenneke C.} and Eijkemans, {Marinus J C} and Koks, {Carolien A M} and {Van Golde}, Ron and Oosterhuis, {Jurjen G E} and Nap, {Annemiek W.} and Scheffer, {Gabrielle J.} and Manger, {Petra A P} and Annemiek Hoek and Mesrure Kaplan and Schoot, {Dick B C} and {van Heusden}, {Arne M.} and Kuchenbecker, {Walter K H} and Perquin, {Denise A M} and Kathrin Fleischer and Kaaijk, {Eugenie M.} and Alexander Sluijmer and Jaap Friederich and Laven, {Joop S E} and {van Hooff}, Marcel and Louwe, {Leonie A.} and Janet Kwee and Boomgaard, {Jantien J.} and {de Koning}, {Corry H.} and Janssen, {Ineke C A H} and Femke Mol and Mol, {Ben W J} and Torrance, {Helen L.} and Broekmans, {Frank J M}",
year = "2012",
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Smit, JG, Kasius, JC, Eijkemans, MJC, Koks, CAM, Van Golde, R, Oosterhuis, JGE, Nap, AW, Scheffer, GJ, Manger, PAP, Hoek, A, Kaplan, M, Schoot, DBC, van Heusden, AM, Kuchenbecker, WKH, Perquin, DAM, Fleischer, K, Kaaijk, EM, Sluijmer, A, Friederich, J, Laven, JSE, van Hooff, M, Louwe, LA, Kwee, J, Boomgaard, JJ, de Koning, CH, Janssen, ICAH, Mol, F, Mol, BWJ, Torrance, HL & Broekmans, FJM 2012, 'The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial', BMC Women's Health, vol. 12, 22. https://doi.org/10.1186/1472-6874-12-22

The inSIGHT study : costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial. / Smit, Janine G.; Kasius, Jenneke C.; Eijkemans, Marinus J C; Koks, Carolien A M; Van Golde, Ron; Oosterhuis, Jurjen G E; Nap, Annemiek W.; Scheffer, Gabrielle J.; Manger, Petra A P; Hoek, Annemiek; Kaplan, Mesrure; Schoot, Dick B C; van Heusden, Arne M.; Kuchenbecker, Walter K H; Perquin, Denise A M; Fleischer, Kathrin; Kaaijk, Eugenie M.; Sluijmer, Alexander; Friederich, Jaap; Laven, Joop S E; van Hooff, Marcel; Louwe, Leonie A.; Kwee, Janet; Boomgaard, Jantien J.; de Koning, Corry H.; Janssen, Ineke C A H; Mol, Femke; Mol, Ben W J; Torrance, Helen L.; Broekmans, Frank J M.

In: BMC Women's Health, Vol. 12, 22, 08.08.2012.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The inSIGHT study

T2 - BMC Women's Health

AU - Smit, Janine G.

AU - Kasius, Jenneke C.

AU - Eijkemans, Marinus J C

AU - Koks, Carolien A M

AU - Van Golde, Ron

AU - Oosterhuis, Jurjen G E

AU - Nap, Annemiek W.

AU - Scheffer, Gabrielle J.

AU - Manger, Petra A P

AU - Hoek, Annemiek

AU - Kaplan, Mesrure

AU - Schoot, Dick B 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 - Laven, Joop S E

AU - van Hooff, Marcel

AU - Louwe, Leonie A.

AU - Kwee, Janet

AU - Boomgaard, Jantien J.

AU - de Koning, Corry H.

AU - Janssen, Ineke C A H

AU - Mol, Femke

AU - Mol, Ben W J

AU - Torrance, Helen L.

AU - Broekmans, Frank J M

PY - 2012/8/8

Y1 - 2012/8/8

N2 - Background: In in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) treatment a large drop is present between embryo transfer and occurrence of pregnancy. The implantation rate per embryo transferred is only 30%. Studies have shown that minor intrauterine abnormalities can be found in 11-45% of infertile women with a normal transvaginal sonography or hysterosalpingography. Two randomised controlled trials have indicated that detection and treatment of these abnormalities by office hysteroscopy after two failed IVF cycles leads to a 9-13% increase in pregnancy rate. Therefore, screening of all infertile women for intracavitary pathology prior to the start of IVF/ICSI is increasingly advocated. In absence of a scientific basis for such a policy, this study will assess the effects and costs of screening for and treatment of unsuspected intrauterine abnormalities by routine office hysteroscopy, with or without saline infusion sonography (SIS), prior to a first IVF/ICSI cycle.Methods/design: Multicenter randomised controlled trial in asymptomatic subfertile women, indicated for a first IVF/ICSI treatment cycle, with normal findings at transvaginal sonography. Women with recurrent miscarriages, prior hysteroscopy treatment and intermenstrual blood loss will not be included. Participants will be randomised for a routine fertility work-up with additional (SIS and) hysteroscopy with on-the-spot-treatment of predefined intrauterine abnormalities versus the regular fertility work-up without additional diagnostic tests. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation. Secondary study outcome parameters are the cumulative implantation rate; cumulative miscarriage rate; patient preference and patient tolerance of a SIS and hysteroscopy procedure. All data will be analysed according to the intention-to-treat principle, using univariate and multivariate logistic regression and cox regression. Cost-effectiveness analysis will be performed to evaluate the costs of the additional tests as routine procedure. In total 700 patients will be included in this study.Discussion: The results of this study will help to clarify the significance of hysteroscopy prior to IVF treatment.Trial registration: NCT01242852.

AB - Background: In in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) treatment a large drop is present between embryo transfer and occurrence of pregnancy. The implantation rate per embryo transferred is only 30%. Studies have shown that minor intrauterine abnormalities can be found in 11-45% of infertile women with a normal transvaginal sonography or hysterosalpingography. Two randomised controlled trials have indicated that detection and treatment of these abnormalities by office hysteroscopy after two failed IVF cycles leads to a 9-13% increase in pregnancy rate. Therefore, screening of all infertile women for intracavitary pathology prior to the start of IVF/ICSI is increasingly advocated. In absence of a scientific basis for such a policy, this study will assess the effects and costs of screening for and treatment of unsuspected intrauterine abnormalities by routine office hysteroscopy, with or without saline infusion sonography (SIS), prior to a first IVF/ICSI cycle.Methods/design: Multicenter randomised controlled trial in asymptomatic subfertile women, indicated for a first IVF/ICSI treatment cycle, with normal findings at transvaginal sonography. Women with recurrent miscarriages, prior hysteroscopy treatment and intermenstrual blood loss will not be included. Participants will be randomised for a routine fertility work-up with additional (SIS and) hysteroscopy with on-the-spot-treatment of predefined intrauterine abnormalities versus the regular fertility work-up without additional diagnostic tests. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation. Secondary study outcome parameters are the cumulative implantation rate; cumulative miscarriage rate; patient preference and patient tolerance of a SIS and hysteroscopy procedure. All data will be analysed according to the intention-to-treat principle, using univariate and multivariate logistic regression and cox regression. Cost-effectiveness analysis will be performed to evaluate the costs of the additional tests as routine procedure. In total 700 patients will be included in this study.Discussion: The results of this study will help to clarify the significance of hysteroscopy prior to IVF treatment.Trial registration: NCT01242852.

KW - Hysteroscopy

KW - IVF

KW - Subfertility

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U2 - 10.1186/1472-6874-12-22

DO - 10.1186/1472-6874-12-22

M3 - Article

VL - 12

JO - BMC Women's Health

JF - BMC Women's Health

SN - 1472-6874

M1 - 22

ER -