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

Autor: Dick B. C. Schoot, Ron J. T. van Golde, Helen L. Torrance, Arne M. van Heusden, Gabrielle J. Scheffer, Jurjen G. E. Oosterhuis, Annemieke Hoek, Jaap Friederich, Frank J.M. Broekmans, Carolien A.M. Koks, Alexander V. Sluijmer, Femke Mol, Petra A. P. Manger, Ben W.J. Mol, Kathrin Fleischer, Leonie A. Louwe, Janine G. Smit, Jantien J. Boomgaard, M. Kaplan, Ineke C. A. H. Janssen, Annemiek W. Nap, Marcel H A Van Hooff, Corry H. de Koning, Joop S.E. Laven, Denise A. M. Perquin, Eugenie M. Kaaijk, Janet Kwee, Walter K. H. Kuchenbecker, Marinus J.C. Eijkemans, Jenneke C. Kasius
Přispěvatelé: Public Health, Erasmus MC other, Obstetrics & Gynecology, Amsterdam Reproduction & Development (AR&D), Center for Reproductive Medicine, Amsterdam Public Health, Obstetrics and Gynaecology, Reproductive Origins of Adult Health and Disease (ROAHD)
Rok vydání: 2012
Předmět:
Pregnancy Rate
medicine.medical_treatment
Cost-Benefit Analysis
law.invention
Study Protocol
Randomized controlled trial
Clinical Protocols
law
Pregnancy
Obstetrics and Gynaecology
OFFICE HYSTEROSCOPY
Single-Blind Method
Hysterosalpingography
Pathogenesis and modulation of inflammation [DCN MP - Plasticity and memory N4i 1]
reproductive and urinary physiology
Netherlands
Ultrasonography
Medicine(all)
Uterine Diseases
medicine.diagnostic_test
Obstetrics
lcsh:Public aspects of medicine
Obstetrics and Gynecology
WOMEN
Patient Preference
General Medicine
Embryo transfer
Intention to Treat Analysis
Treatment Outcome
Hysteroscopy
IVF
embryonic structures
Female
therapeutics
Infertility
Female
medicine.medical_specialty
HYSTEROSALPINGOGRAPHY
Fertilization in Vitro
EMBRYO-TRANSFER
lcsh:Gynecology and obstetrics
medicine
Humans
Sperm Injections
Intracytoplasmic
lcsh:RG1-991
DIAGNOSTIC HYSTEROSCOPY
Proportional Hazards Models
Gynecology
UTERINE CAVITY
In vitro fertilisation
Intention-to-treat analysis
business.industry
urogenital system
Uterus
Subfertility
lcsh:RA1-1270
medicine.disease
Pregnancy rate
Human Reproduction [NCEBP 12]
PREGNANCY RATES
Logistic Models
Reproductive Medicine
Multivariate Analysis
business
IN-VITRO FERTILIZATION
Zdroj: BMC Womens Health, 12. BioMed Central Ltd.
BMC Women's health, 12(1). BioMed Central
BMC Womens Health, 12:22. BioMed Central Ltd.
BMC Women's Health, 12, pp. 22-22
BMC Women's Health
BMC Women's Health, Vol 12, Iss 1, p 22 (2012)
BMC Women's Health, 12
BMC Women's Health, 12, 22-22
ISSN: 1472-6874
Popis: Contains fulltext : 109856.pdf (Publisher’s version ) (Open Access) 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.
Databáze: OpenAIRE
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