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Open Access Study protocol

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

Janine G Smit1*, Jenneke C Kasius1, Marinus JC Eijkemans2, Carolien AM Koks3, Ron Van Golde4, Jurjen GE Oosterhuis5, Annemiek W Nap6, Gabrielle J Scheffer7, Petra AP Manger8, Annemiek Hoek9, Mesrure Kaplan10, Dick BC Schoot11, Arne M van Heusden12, Walter KH Kuchenbecker13, Denise AM Perquin14, Kathrin Fleischer15, Eugenie M Kaaijk16, Alexander Sluijmer17, Jaap Friederich18, Joop SE Laven19, Marcel van Hooff20, Leonie A Louwe21, Janet Kwee20, Jantien J Boomgaard22, Corry H de Koning23, Ineke CAH Janssen24, Femke Mol25, Ben WJ Mol26, Helen L Torrance1 and Frank JM Broekmans1

Author affiliations

1 Department of Reproductive Medicine and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands

2 University Medical Center Utrecht, Julius Center for Health Sciences and Primary care, Utrecht, The Netherlands

3 Department of Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, The Netherlands

4 Department of Obstetrics and Gynaecology, Maastricht University Medical Center, University of Maastricht, Maastricht, The Netherlands

5 Department of Obstetrics and Gynaecology, Medical Spectrum Twente, Enschede, The Netherlands

6 Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, The Netherlands

7 Department of Obstetrics and Gynaecology, Gelre Hospital, Apeldoorn, The Netherlands

8 Department of Obstetrics and Gynaecology, Diakonessen Hospital Utrecht, Utrecht, The Netherlands

9 Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

10 Department of Obstetrics and Gynaecology, Ropcke-Zweers hospital, Hardenberg, The Netherlands

11 Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, The Netherlands

12 Department of Obstetrics and Gynaecology, Antonius Hospital, Nieuwegein, The Netherlands

13 Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, The Netherlands

14 Department of Obstetrics and Gynaecology, Medical Center Leeuwarden, Leeuwarden, The Netherlands

15 Department of Obstetrics and Gynaecology, University Medical Center St Radboud, Nijmegen, The Netherlands

16 Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

17 Department of Obstetrics and Gynaecology, Wilhelmina Hospital, Assen, The Netherlands

18 Department of Obstetrics and Gynaecology, Gemini Hospital, Den Helder, The Netherlands

19 Department of Obstetrics and Gynaecology, Division of Reproductive Medicine, Erasmus MC, Rotterdam, The Netherlands

20 Department of Obstetrics and Gynaecology, Sint Franciscus Gasthuis, Rotterdam, The Netherlands

21 Department of Gynaecology and Reproductive Medicine, Leids University Medical Center, University of Leiden, Leiden, The Netherlands

22 Department of Obstetrics and Gynaecology, Westfriesgasthuis, Hoorn, The Netherlands

23 Department of Obstetrics and Gynaecology, Tergooi hospitals, Blaricum, The Netherlands

24 Department of Obstetrics and Gynaecology, Groene Hart Hospital, Gouda, The Netherlands

25 Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Academic Medical Centre, Amsterdam, The Netherlands

26 Department of Obstetrics and Gynaecology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

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Citation and License

BMC Women's Health 2012, 12:22  doi:10.1186/1472-6874-12-22

Published: 8 August 2012

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; Subfertility; IVF