Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342)

BMC Women's Health

Study Protocol

F. Mol¹  M. L. Bandell²  A. Preys-Bosman³  J. Visser⁴  M. van Rumste⁵  L. F. van der Voet⁶  A. P. Manger⁷  M. van Wely⁸  J. S. E. Laven⁹  M. Verberg^1,10  E. Scheenjes^1,11  M. A. F. Traas^1,12  C. Janssen^1,13  Q. D. Pieterse^1,14  B. Cohlen^1,15  G. Teklenburg^1,15  J. P. de Bruin^1,16  F. W. Jansen^1,17  R. van Oppenraaij^1,18  J. E. den Hartog^1,19  J. W. M. Maas^2,20  E. Brinkhuis^2,21  W. Hermes^2,22  M. Nijs^2,23  E.R. Groenewoud^2,24  E. Moll^2,25  K. Fleischer^2,26  J.C. Boxmeer^2,27  M. J. Pelinck^2,28  J. van Disseldorp^2,29  J. Smeenk^3,30  M. H. van Hooff^3,31  C. de Koning^3,32  A. Cantineau^3,33  F. J. M. Broekmans^3,34  M. J. C. Eijkemans^3,34  N. E. van Hoogenhuijze^3,34  H. L. Torrance^3,34  J. C. Kasius^3,34  C. B. Lambalk^3,35  A. Sluijmer^3,36 

[1] Academic Medical Center Amsterdam, Amsterdam, The Netherlands;Albert Schweitzer Hospital, Sliedrecht, The Netherlands;Alrijne Hospital, Leiderdorp, The Netherlands;Amphia Hospital, Breda, The Netherlands;Catharina Hospital, Eindhoven, The Netherlands;Deventer Hospital, Deventer, The Netherlands;Diakonessenhuis, Utrecht, The Netherlands;Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynecology – NVOG Consortium 2.0, Dutch, The Netherlands;Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands;Fertility Clinic Twente, Hengelo, The Netherlands;Gelderse Vallei Hospital, Ede, The Netherlands;Gelre Hospital, Apeldoorn, The Netherlands;Groene Hart Hospital, Gouda, The Netherlands;Haga Hospital, The Hague, The Netherlands;Isala Fertilityclinic, Zwolle, The Netherlands;Jeroen Bosch Hospital, Den Bosch, The Netherlands;Leiden University Medical Center, Leiden, The Netherlands;Maasstad Hospital, Rotterdam, The Netherlands;Maastricht University Medical Center, Maastricht, The Netherlands;Maxima Medical Center, Veldhoven, The Netherlands;Meander Medical Center, Amersfoort, The Netherlands;Medical Center Haaglanden-Bronovo-Nebo, The Hague, The Netherlands;Nij Geertgen, Elsendorp, The Netherlands;Noordwest Ziekenhuisgroep, Den Helder, The Netherlands;Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands;Radboud University Medical Center, Nijmegen, The Netherlands;Reinier de Graaf Gasthuis, Delft, The Netherlands;Scheper Hospital, Emmen, The Netherlands;St. Antonius Hospital, Nieuwegein, The Netherlands;St. Elisabeth-Twee Steden Hospital, Tilburg, The Netherlands;St. Franciscus Gasthuis, Rotterdam, The Netherlands;Ter Gooi Hospital, Hilversum, The Netherlands;University Medical Center Groningen, Groningen, The Netherlands;University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands;Vrije Universiteit Medical Center, Amsterdam, The Netherlands;Wilhelmina Hospital Assen, Assen, The Netherlands;

关键词: Endometrial injury;    Endometrial scratching;    Endometrial scratch;    In vitro fertilization;    Intracytoplasmic sperm injection;    IVF;    ICSI;    Implantation failure;   

DOI  :  10.1186/s12905-017-0378-y

 received in 2016-09-27, accepted in 2017-03-07,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundSuccess rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation. Mechanical endometrial injury, also called ‘scratching’, has been proposed to positively affect the chance of implantation after embryo transfer, but the currently available evidence is not yet conclusive. The primary aim of this study is to determine the effect of endometrial scratching prior to a second fresh in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle on live birth rates in women with a failed first IVF/ICSI cycle.MethodMulticenter randomized controlled trial in Dutch academic and non-academic hospitals. A total of 900 women will be included of whom half will undergo an endometrial scratch in the luteal phase of the cycle prior to controlled ovarian hyperstimulation using an endometrial biopsy catheter. The primary endpoint is the live birth rate after the 2nd fresh IVF/ICSI cycle. Secondary endpoints are costs, cumulative live birth rate (after the full 2nd IVF/ICSI cycle and over 12 months of follow-up); clinical and ongoing pregnancy rate; multiple pregnancy rate; miscarriage rate and endometrial tissue parameters associated with implantation failure.DiscussionMultiple studies have been performed to investigate the effect of endometrial scratching on live birth rates in women undergoing IVF/ICSI cycles. Due to heterogeneity in both the method and population being scratched, it remains unclear which group of women will benefit from the procedure. The SCRaTCH trial proposed here aims to investigate the effect of endometrial scratching prior to controlled ovarian hyperstimulation in a large group of women undergoing a second IVF/ICSI cycle.Trial registrationNTR 5342, registered July 31st, 2015.Protocol versionVersion 4.10, January 4th, 2017.

【 授权许可】

CC BY   
© The Author(s). 2017