Study protocol
The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial
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
Citation and License
BMC Women's Health 2012, 12:22 doi:10.1186/1472-6874-12-22
Published: 8 August 2012Abstract
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
