The OPTIMIST study: optimisation of cost effectiveness through individualised FSH stimulation dosages for IVF treatment. A randomised controlled trial

BMC Women's Health

Study Protocol

Ben Willem J Mol¹  Fulco van der Veen¹  Petra A Manger²  Joop SE Laven³  Gabrielle J Scheffer⁴  Jaap Friederich⁵  Walter KH Kuchenbecker⁶  Jan Peter de Bruin⁷  Frans M Helmerhorst⁸  Arie Verhoeff⁹  Ron JT van Golde^1,10  Carolien AM Koks^1,11  Egbert A Brinkhuis^1,12  Harold R Verhoeve^1,13  Annemiek W Nap^1,14  Arne M van Heusden^1,15  Jesper MJ Smeenk^1,16  Marcel HA van Hooff^1,17  Janet Kwee^1,18  Annemieke Hoek^1,19  Kathrin Fleischer^2,20  Cornelis B Lambalk^2,21  Alexander V Sluijmer^2,22  Helen L Torrance^2,23  Frank JM Broekmans^2,23  Theodora C van Tilborg^2,23  Marinus JC Eijkemans^2,24 

[1] Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Diakonessen Hospital Utrecht, Utrecht, The Netherlands;Department of Obstetrics and Gynaecology, Division of Reproductive Medicine, Erasmus Medical Centre, Rotterdam, The Netherlands;Department of Obstetrics and Gynaecology, Gelre Hospital, Apeldoorn, The Netherlands;Department of Obstetrics and Gynaecology, Gemini Hospital, Den Helder, The Netherlands;Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, The Netherlands;Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, Den Bosch, The Netherlands;Department of Obstetrics and Gynaecology, Leids University Medical Centre, University of Leiden, Leiden, The Netherlands;Department of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, The Netherlands;Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, University of Maastricht, Maastricht, The Netherlands;Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, The Netherlands;Department of Obstetrics and Gynaecology, Meander Medical Centre, Amersfoort, The Netherlands;Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Hospital, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, The Netherlands;Department of Obstetrics and Gynaecology, St Antonius Hospital, Nieuwegein, The Netherlands;Department of Obstetrics and Gynaecology, St Elisabeth Hospital, Tilburg, The Netherlands;Department of Obstetrics and Gynaecology, St Fransiscus Hospital, Rotterdam, The Netherlands;Department of Obstetrics and Gynaecology, St Lucas Andreas Hospital, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands;Department of Obstetrics and Gynaecology, University Medical Centre St Radboud, Nijmegen, The Netherlands;Department of Obstetrics and Gynaecology, VU University Medical Centre, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Wilhelmina Hospital, Assen, The Netherlands;Department of Reproductive Medicine and Gynaecology, University Medical Centre Utrecht, University of Utrecht, Utrecht, The Netherlands;Julius Centre for Health Sciences and Primary care, University Medical Centre Utrecht, Utrecht, The Netherlands;

关键词: Ovarian reserve;    Antral follicle count;    IVF;    Individualised FSH stimulation dosages;    Live birth rate;   

DOI  :  10.1186/1472-6874-12-29

 received in 2012-08-01, accepted in 2012-09-03,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundCosts of in vitro fertilisation (IVF) are high, which is partly due to the use of follicle stimulating hormone (FSH). FSH is usually administered in a standard dose. However, due to differences in ovarian reserve between women, ovarian response also differs with potential negative consequences on pregnancy rates. A Markov decision-analytic model showed that FSH dose individualisation according to ovarian reserve is likely to be cost-effective in women who are eligible for IVF. However, this has never been confirmed in a large randomised controlled trial (RCT). The aim of the present study is to assess whether an individualised FSH dose regime based on an ovarian reserve test (ORT) is more cost-effective than a standard dose regime.Methods/DesignMulticentre RCT in subfertile women indicated for a first IVF or intracytoplasmic sperm injection cycle, who are aged < 44 years, have a regular menstrual cycle and no major abnormalities at transvaginal sonography. Women with polycystic ovary syndrome, endocrine or metabolic abnormalities and women undergoing IVF with oocyte donation, will not be included. Ovarian reserve will be assessed by measuring the antral follicle count. Women with a predicted poor response or hyperresponse will be randomised for a standard versus an individualised FSH regime (150 IU/day, 225-450 IU/day and 100 IU/day, respectively). Participants will undergo a maximum of three stimulation cycles during maximally 18 months. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months after randomisation. Secondary outcomes are parameters for ovarian response, multiple pregnancies, number of cycles needed per live birth, total IU of FSH per stimulation cycle, and costs. All data will be analysed according to the intention-to-treat principle. Cost-effectiveness analysis will be performed to assess whether the health and associated economic benefits of individualised treatment of subfertile women outweigh the additional costs of an ORT.DiscussionThe results of this study will be integrated into a decision model that compares cost-effectiveness of the three dose-adjustment strategies to a standard dose strategy. The study outcomes will provide scientific foundation for national and international guidelines.Trial registrationNTR2657

【 授权许可】

CC BY   
© van Tilborg et al.; licensee BioMed Central Ltd. 2012