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)

Hoogenhuijze, N E van; Torrance, Helen L.; Mol, Femke; Laven, Joop; Scheenjes, Eduard; Traas, Maaike A. F.; Janssen, Catharina A.H.; Cohlen, Ben J; Teklenburg, Gijs; Bruin, Jan Peter de; Oppenraaij, R. van; Maas, Jacques W.M.; Moll, Etelka; Fleischer, Kathrin; Hooff, M. H. van; Koning, C. de; Cantineau, Astrid E. P.; Lambalk, Cornelis B.; Verberg, M.F.G.; Nijs, Martine; Manger, A Petra; Rumste, Minouche van; Voet, Lucy F. van der; Preys-Bosman, A.; Visser, Jantien; Brinkhuis, Egbert A.; Hartog, J.E. den; Sluijmer, Alexander V.; Jansen, Frank Willem; Hermes, Wietske; Bandell, M L; Pelinck, M. J.; Disseldorp, Jeroen van; Wely, Madelon van; Smeenk, J.M.J.; Pieterse, Q. D.; Boxmeer, Jolanda C.; Groenewoud, Eva R.; Eijkemans, Marinus J.C.; Kasius, Jenneke C.; Broekmans, Frank J.

doi:10.1186/s12905-017-0378-y

Cited by 30 publications

(19 citation statements)

References 24 publications

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“…Despite the concerns around the quality of evidence in using ES and that many of the trials undertaken so far have been small (most <150 participants), ES has been widely adopted into routine clinical practice in women with recurrent unsuccessful implantation and is currently being provided in some fertility units where women are having IVF/intracytoplasmic sperm injection (ICSI) for the first time. 10 11 Two large trials are currently in progress to determine if ES is beneficial in women undergoing their second IVF cycle 12 and a sample of women undergoing any IVF cycle. 13 Therefore, given the lack of evidence for the effectiveness of ES in women undergoing their first cycle of IVF/ICSI, it is essential that a large well-controlled multicentre trial is conducted to fully investigate the effectiveness and safety of this technique.…”

Section: Introductionmentioning

confidence: 99%

Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial

et al. 2018

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IntroductionEndometrial trauma commonly known as endometrial scratch (ES) has been shown to improve pregnancy rates in women with a history of repeated implantation failure undergoing in vitro fertilisation (IVF), with or without intracytoplasmic sperm injection (ICSI). However, the procedure has not yet been fully explored in women having IVF/ICSI for the first time. This study aims to examine the effect of performing an ES in the mid-luteal phase prior to a first-time IVF/ICSI cycle on the chances of achieving a clinical pregnancy and live birth. If ES can influence this success rate, there would be a significant cost saving to the National Health Service through decreasing the number of IVF/ICSI cycles necessary to achieve a pregnancy, increase the practice of single embryo transfer and consequently have a large impact on risks and costs associated with multiple pregnancies.Methods and analysisThis 30-month, UK, multicentre, parallel group, randomised controlled trial includes a 9-month internal pilot and health economic analysis recruiting 1044 women from 16 fertility units. It will follow up participants to identify if IVF/ICSI has been successful and live birth has occurred up to 6 weeks post partum. Primary analysis will be on an intention-to-treat basis. A substudy of endometrial samples obtained during the ES will assess the role of immune factors in embryo implantation. Main trial recruitment commenced on January 2017 and is ongoing.Participants randomised to the intervention group will receive the ES procedure in the mid-luteal phase of the preceding cycle prior to first-time IVF/ICSI treatment versus usual IVF/ICSI treatment in the control group, with 1:1 randomisation. The primary outcome is live birth rate after completed 24 weeks gestation.Ethics and disseminationSouth Central—Berkshire Research Ethics Committee approved the protocol. Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences.Trial registration numberISRCTN23800982; Pre-results.

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Section: Introductionmentioning

confidence: 99%

Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial

et al. 2018

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“…These criticisms were later strengthened by more recent RCTs that failed to show any pragmatic benefit of endometrial scratching (Yeung et al , 2014; Gibreel et al , 2015). However, the topic of endometrial scratching remains a contentious and unresolved matter with multiple research groups attempting to evaluate its benefits in ongoing RCTs (Nastri et al , 2015; Lensen et al , 2016; van Hoogenhuijze et al , 2017).…”

Section: Introduction and Rationalementioning

confidence: 99%

Endometrial receptivity enhancement through induced injury and repair during ovarian stimulation: the Receptivity Enhancement by Follicular-phase Renewal after Endometrial ScratcHing (REFRESH) trial protocol

Santos‐Ribeiro

Mackens

Tournaye

et al. 2017

Human Reproduction Open

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STUDY QUESTION Does intentional endometrial injury (i.e. endometrial scratching) during ART enhance pregnancy rates? SUMMARY ANSWER We propose a randomized controlled clinical trial in women performing ART in which the intervention group will undergo an additional endometrial biopsy during exogenous ovarian stimulation. WHAT IS KNOWN ALREADY Although endometrial receptivity has been extensively studied, the mechanisms behind the implantation of an embryo remain largely a mystery. Intentional endometrial injury has been put forward by many researchers as an inexpensive clinical tool capable of enhancing endometrial receptivity. However, despite its widespread use, the benefit of endometrial scratching is still a contentious and unresolved issue. STUDY DESIGN, SIZE, DURATION Pragmatic two-arm randomized, single-centre, controlled open-label trial in women undergoing exogenous gonadotropin ovarian stimulation for ART followed by a fresh embryo transfer in a gonadotropin-releasing hormone antagonist suppressed cycle. The trial will include 360 women in total with a 1:1 allocation ratio and an expected total duration of up to 45 months. PARTICIPANTS/MATERIALS, SETTING, METHODS Subjects in the intervention group will undergo an endometrial biopsy during the follicular phase, on the sixth to eighth day of exogenous stimulation. Furthermore, nested within this clinical trial, we will also evaluate whether the transcriptomic signatures of the material collected during the biopsy may accurately distinguish women who become pregnant from those who do not. These endometrial transcriptomic signatures will be assessed both immediately after the biopsy and following in-vitro decidualization. MAIN RESULTS AND THE ROLE OF CHANCE Our primary objective is to assess the effect of endometrial injury during exogenous gonadotropin ovarian stimulation on clinical pregnancy rates after ART. Secondary efficacy and safety outcomes include: live-birth delivery after 24 weeks, the endometrial transcriptomic profile among women in the intervention group, short-term safety (e.g. procedure intolerance due to pain, post-procedure bleeding) and long-term safety (e.g. cancelled transfers, miscarriage) outcomes. LIMITATIONS, REASONS FOR CAUTION Owing to its pragmatic design, this study may have limited power to determine one or more of our secondary outcomes and whether there are specific subgroups of women who may benefit significantly from performing endometrial scratching and endometrial transcriptomic profiling. WIDER IMPLICATIONS OF THE FINDINGS Despite the weak biological plausibility, heterogeneity in the existing randomized controlled trials and lack of evaluation of any potential risks associated with endometrial scratching, this procedure is still widely applied in current clinic...

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“…The outcome of ongoing prospective randomized controlled trials that aim to investigate the clinical outcome of LEI prior to the IVF cycle may give more concrete data. [20][21][22] S So ou ur rc ce e o of f F Fi in na an nc ce e During this study, no financial or spiritual support was received neither from any pharmaceutical company that has a direct connection with the research subject, nor from a company that provides or produces medical instruments and materials which may negatively affect the evaluation process of this study. C Co on nf fl li ic ct t o of f I In nt te er re es st t No conflicts of interest between the authors and / or family members of the scientific and medical committee members or members of the potential conflicts of interest, counseling, expertise, working conditions, share holding and similar situations in any firm.…”

Section: Resultsmentioning

confidence: 99%

Is There any Impact of Local Endometrial Injury on Implantation and Clinical Pregnancy Rates in the First in Vitro Fertilization Cycles

Cüylan¹,

Demır²,

Dilbaz³

et al. 2019

JCOG

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mplantation is one of the most crucial steps for a successful in-vitro fertilization (IVF)-embryo transfer (ET). Implantation success depends on the quality of the embryo and endometrial receptivity. Even with a good quality embryo transfer, the rates of implantation may vary between 25-30% per transferred embryo. 1,2 Implantation occurs during the "implantation window", which is the period between the 19 th and 23 rd days of the menstrual cycle, when endometrial receptivity is at its peak, and includes a three-stage process of apposition, adhesion and invasion of the blastocyst to the endometrium.Recently, local endometrial injury (LEI) has been proposed as one of the methods that aim to increase the implantation rates in IVF-ET cycles. Initially, Barash et al. showed an increase in implantation and pregnancy rates in 134 women who had repeated endometrial biopsies as a method of LEI before IVF-ET cycles. 3 Likewise, other studies have also demonstrated an increase in pregnancy rates after LEI in women with recurrent IVF failure. 4,5 The first study investigating the effect of LEI on implantation and JCOG. 2019;29(4):129-35 129 A AB BS S T TR RA AC CT T O Ob bj je ec ct ti iv ve e: : To evaluate the impact of local endometrial injury (LEI), applied during the first in vitro fertilization (IVF)-embryo transfer (ET) cycle using office hysteroscopy, on implantation and pregnancy rates. M Ma at te er ri ia al l a an nd d M Me et th ho od ds s: : A total of 372 women under the age of 40, who had their first IVF-ET treatment cycle, with no ovulatory or intracavitary pathology were included in this study. LEI was created in the fundus, anterior and posterior endometrial walls during office hysteroscopy, which was performed prior to the IVF-ET cycle. Long luteal gonadotropin releasing hormone agonist protocol was used in all cycles and 273 patients underwent embryo transfer. Implantation and pregnancy rates were compared to the control group. R Re es su ul lt ts s: : Age, body mass index, baseline follicle stimulating hormone, luteinizing hormone, and estradiol levels, antral follicle counts, infertility etiologies, total oocyte counts, intra-cytoplasmic sperm injection percentages were similar, both in the study and the control groups. Clinical pregnancy rates (28.7% vs 26.1%, p>0.05), total pregnancy rates (43.1% vs 38%, p>0.05) and implantation rates (19% vs 12.9%, p>0.05) of the LEI injury group were higher than those of the control group, however the difference was not statistically significant. There was no statistically significant difference between the miscarriage rates. C Co on nc cl lu us si io on n: : Even if implantation and pregnancy rates improved slightly in LEI group, the study did not reveal a significant improvement for the implantation and pregnancy rates after the LEI, which was created during hysteroscopy before the first IVF-RT treatment cycle. K Ke ey yw wo or rd ds s: : Embryo transfer; implantation; in vitro fertilization; local endometrial injury; office hysteroscopy

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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)

Cited by 30 publications

References 24 publications

Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial

Induced endometrial trauma (endometrial scratch) in the mid-luteal menstrual cycle phase preceding first cycle IVF/ICSI versus usual IVF/ICSI therapy: study protocol for a randomised controlled trial

Endometrial receptivity enhancement through induced injury and repair during ovarian stimulation: the Receptivity Enhancement by Follicular-phase Renewal after Endometrial ScratcHing (REFRESH) trial protocol

Is There any Impact of Local Endometrial Injury on Implantation and Clinical Pregnancy Rates in the First in Vitro Fertilization Cycles

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