Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2012 Aug 8:12:22.
doi: 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

Janine G Smit  1 , 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
Affiliations
Randomized Controlled Trial

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

Janine G Smit et al. BMC Womens Health. .

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flowchart inSIGHT study.
See this image and copyright information in PMC

References

    1. Bouwmans CA, Lintsen BM, Eijkemans MJ, Habbema JD, Braat DD, Hakkaart L. A detailed cost analysis of in vitro fertilization and intracytoplasmic sperm injection treatment. Fertil Steril. 2008;89(2):331–341. doi: 10.1016/j.fertnstert.2007.03.003. - DOI - PubMed
    1. Rogers PA, Milne BJ, Trounson AO. A model to show human uterine receptivity and embryo viability following ovarian stimulation for in vitro fertilization. J In Vitro Fert Embryo Transf. 1986;3(2):93–98. doi: 10.1007/BF01139353. - DOI - PubMed
    1. Shamma FN, Lee G, Gutmann JN, Lavy G. The role of office hysteroscopy in in vitro fertilization. Fertil Steril. 1992;58(6):1237–1239. - PubMed
    1. La Sala GB, Montanari R, Dessanti L, Cigarini C, Sartori F. The role of diagnostic hysteroscopy and endometrial biopsy in assisted reproductive technologies. Fertil Steril. 1998;70(2):378–380. doi: 10.1016/S0015-0282(98)00147-2. - DOI - PubMed
    1. Oliveira FG, Abdelmassih VG, Diamond MP, Dozortsev D, Nagy ZP, Abdelmassih R. Uterine cavity findings and hysteroscopic interventions in patients undergoing in vitro fertilization-embryo transfer who repeatedly cannot conceive. Fertil Steril. 2003;80(6):1371–1375. doi: 10.1016/j.fertnstert.2003.05.003. - DOI - PubMed

Publication types

MeSH terms

Associated data