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, 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, 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, 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

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.

Figures

Figure 1
Figure 1
Flowchart inSIGHT study.

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Source: PubMed

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