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Endometrial scratching in women with one failed IVF/ICSI cycle-outcomes of a randomised controlled trial (SCRaTCH).
Hum Reprod. 2021 01 01; 36(1):87-98.HR

Abstract

STUDY QUESTION

Does endometrial scratching in women with one failed IVF/ICSI treatment affect the chance of a live birth of the subsequent fresh IVF/ICSI cycle?

SUMMARY ANSWER

In this study, 4.6% more live births were observed in the scratch group, with a likely certainty range between -0.7% and +9.9%.

WHAT IS KNOWN ALREADY

Since the first suggestion that endometrial scratching might improve embryo implantation during IVF/ICSI, many clinical trials have been conducted. However, due to limitations in sample size and study quality, it remains unclear whether endometrial scratching improves IVF/ICSI outcomes.

STUDY DESIGN, SIZE, DURATION

The SCRaTCH trial was a non-blinded randomised controlled trial in women with one unsuccessful IVF/ICSI cycle and assessed whether a single endometrial scratch using an endometrial biopsy catheter would lead to a higher live birth rate after the subsequent IVF/ICSI treatment compared to no scratch. The study took place in 8 academic and 24 general hospitals. Participants were randomised between January 2016 and July 2018 by a web-based randomisation programme. Secondary outcomes included cumulative 12-month ongoing pregnancy leading to live birth rate.

PARTICIPANTS/MATERIALS, SETTING, METHODS

Women with one previous failed IVF/ICSI treatment and planning a second fresh IVF/ICSI treatment were eligible. In total, 933 participants out of 1065 eligibles were included (participation rate 88%).

MAIN RESULTS AND THE ROLE OF CHANCE

After the fresh transfer, 4.6% more live births were observed in the scratch compared to control group (110/465 versus 88/461, respectively, risk ratio (RR) 1.24 [95% CI 0.96-1.59]). These data are consistent with a true difference of between -0.7% and +9.9% (95% CI), indicating that while the largest proportion of the 95% CI is positive, scratching could have no or even a small negative effect. Biochemical pregnancy loss and miscarriage rate did not differ between the two groups: in the scratch group 27/153 biochemical pregnancy losses and 14/126 miscarriages occurred, while this was 19/130 and 17/111 for the control group (RR 1.21 (95% CI 0.71-2.07) and RR 0.73 (95% CI 0.38-1.40), respectively). After 12 months of follow-up, 5.1% more live births were observed in the scratch group (202/467 versus 178/466), of which the true difference most likely lies between -1.2% and +11.4% (95% CI).

LIMITATIONS, REASONS FOR CAUTION

This study was not blinded. Knowledge of allocation may have been an incentive for participants allocated to the scratch group to continue treatment in situations where they may otherwise have cancelled or stopped. In addition, this study was powered to detect a difference in live birth rate of 9%.

WIDER IMPLICATIONS OF THE FINDINGS

The results of this study are an incentive for further assessment of the efficacy and clinical implications of endometrial scratching. If a true effect exists, it may be smaller than previously anticipated or may be limited to specific groups of women undergoing IVF/ICSI. Studying this will require larger sample sizes, which will be provided by the ongoing international individual participant data-analysis (PROSPERO CRD42017079120). At present, endometrial scratching should not be performed outside of clinical trials.

STUDY FUNDING/COMPETING INTEREST(S)

This study was funded by ZonMW, the Dutch organisation for funding healthcare research. J.S.E. Laven reports grants and personal fees from AnshLabs (Webster, Tx, USA), Ferring (Hoofddorp, The Netherlands) and Ministry of Health (CIBG, The Hague, The Netherlands) outside the submitted work. A.E.P. Cantineau reports 'other' from Ferring BV, personal fees from Up to date Hyperthecosis, 'other' from Theramex BV, outside the submitted work. E.R. Groenewoud reports grants from Titus Health Care during the conduct of the study. A.M. van Heusden reports personal fees from Merck Serono, personal fees from Ferring, personal fees from Goodlife, outside the submitted work. F.J.M. Broekmans reports personal fees as Member of the external advisory board for Ferring BV, The Netherlands, personal fees as Member of the external advisory board for Merck Serono, The Netherlands, personal fees as Member of the external advisory for Gedeon Richter, Belgium, personal fees from Educational activities for Ferring BV, The Netherlands, grants from Research support grant Merck Serono, grants from Research support grant Ferring, personal fees from Advisory and consultancy work Roche, outside the submitted work. C.B. Lambalk reports grants from Ferring, grants from Merck, grants from Guerbet, outside the submitted work.

TRIAL REGISTRATION NUMBER

Registered in the Netherlands Trial Register (NL5193/NTR 5342).

TRIAL REGISTRATION DATE

31 July 2015.

DATE OF FIRST PATIENT’S ENROLMENT

26 January 2016.

Authors+Show Affiliations

Department of Gynaecology & Reproductive Medicine, University Medical Centre Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, the Netherlands.Amsterdam UMC, University of Amsterdam, Center for Reproductive Medicine, Reproduction and Development, Meibergdreef 9, Amsterdam, the Netherlands.Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, Erasmus Medical Centre Rotterdam, 3015 GD, Rotterdam, the Netherlands.Department of Obstetrics, Gynaecology & Reproductive Medicine, Noordwest Ziekenhuisgroep, 1782 GZ, Den Helder, the Netherlands.Department of Gynaecology, Gelre Hospital, 7334 DZ, Apeldoorn, the Netherlands.Department of Gynaecology, Groene Hart Hospital, 2803 HH, Gouda, the Netherlands.Isala Fertility Clinic, Isala Hospital, 8025 AB, Zwolle, the Netherlands.Department of Gynaecology & Obstetrics, Jeroen Bosch Hospital, 5223 GZ, Den Bosch, the Netherlands.Department of Gynaecology, Maasstad Hospital, 3079 DZ, Rotterdam, the Netherlands.Department of Gynaecology, Maxima Medical Centre, 5504 DB, Veldhoven, the Netherlands.Department of Gynaecology, Onze Lieve Vrouwe Gasthuis, 1061 AE, Amsterdam, the Netherlands.Department of Obstetrics & Gynaecology, Radboud University Medical Centre, 6525 GA, Nijmegen, the Netherlands.Department of Gynaecology, Franciscus Gasthuis en Vlietland, 3045 PM, Rotterdam, the Netherlands.Department of Gynaecology, Tergooi Hospital, 1213 XZ, Hilversum, the Netherlands.University of Groningen, University Medical Center Groningen, Hanzeplein 1, Groningen, the Netherlands.Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, 1081 HV, Amsterdam, The Netherlands.Fertility Clinic, Fertility Clinic Twente, 7556 BN, Hengelo, the Netherlands.Fertility Clinic, Medisch Centrum Kinderwens, 2353 GA, Leiderdorp, the Netherlands.Department of Gynaecology, Diakonessenhuis, 3582 KE, Utrecht, the Netherlands.Department of Gynaecology, Catharina Hospital, 5623 EJ, Eindhoven, the Netherlands.Department of Gynaecology, Deventer Hospital, 7416 SE, Deventer, the Netherlands.Fertility Center, Haga Hospital, 2545 AA, The Hague, the Netherlands.Department of Gynaecology & Obstetrics, Amphia Hospital, 4818 CK, Breda, the Netherlands.Department of Gynaecology & Obstetrics, Meander Hospital, 3813 TZ, Amersfoort, the Netherlands.Department of Obstetrics & Gynaecology, Maastricht University Medical Centre, 6229 HX, Maastricht, the Netherlands.Fertility clinic, Wilhelmina Hospital Assen, 9401 RK, Assen, the Netherlands.Department of Gynaecology, Leiden University Medical Centre, 2333 ZA, Leiden, the Netherlands.Department of Gynaecology, Haaglanden Medical Centre, 2512 VA, The Hague, the Netherlands.Department of Gynaecology, Albert Schweitzer Hospital, 3364 DA, Sliedrecht,the Netherlands.Department of Gynaecology, Reinier de Graaf Gasthuis, 2625 AD, Delft, the Netherlands.Department of Gynaecology & Obstetrics, St. Antonius Hospital, 3435 CM, Nieuwegein, the Netherlands.Department of Reproductive Medicine, Elisabeth-TweeSteden Hospital, 5042 AD, Tilburg, the Netherlands.Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynaecology - NVOG Consortium 2.0.Department of Gynaecology & Reproductive Medicine, University Medical Centre Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, the Netherlands. Julius Centre for Health Sciences and Primary Care, Department of Medical Humanities, University Medical Centre Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, the Netherlands.Department of Gynaecology & Reproductive Medicine, University Medical Centre Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, the Netherlands.Department of Gynaecology & Reproductive Medicine, University Medical Centre Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, the Netherlands.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

33289528

Citation

van Hoogenhuijze, N E., et al. "Endometrial Scratching in Women With One Failed IVF/ICSI Cycle-outcomes of a Randomised Controlled Trial (SCRaTCH)." Human Reproduction (Oxford, England), vol. 36, no. 1, 2021, pp. 87-98.
van Hoogenhuijze NE, Mol F, Laven JSE, et al. Endometrial scratching in women with one failed IVF/ICSI cycle-outcomes of a randomised controlled trial (SCRaTCH). Hum Reprod. 2021;36(1):87-98.
van Hoogenhuijze, N. E., Mol, F., Laven, J. S. E., Groenewoud, E. R., Traas, M. A. F., Janssen, C. A. H., Teklenburg, G., de Bruin, J. P., van Oppenraaij, R. H. F., Maas, J. W. M., Moll, E., Fleischer, K., van Hooff, M. H. A., de Koning, C. H., Cantineau, A. E. P., Lambalk, C. B., Verberg, M., van Heusden, A. M., Manger, A. P., ... Broekmans, F. J. M. (2021). Endometrial scratching in women with one failed IVF/ICSI cycle-outcomes of a randomised controlled trial (SCRaTCH). Human Reproduction (Oxford, England), 36(1), 87-98. https://doi.org/10.1093/humrep/deaa268
van Hoogenhuijze NE, et al. Endometrial Scratching in Women With One Failed IVF/ICSI Cycle-outcomes of a Randomised Controlled Trial (SCRaTCH). Hum Reprod. 2021 01 1;36(1):87-98. PubMed PMID: 33289528.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Endometrial scratching in women with one failed IVF/ICSI cycle-outcomes of a randomised controlled trial (SCRaTCH). AU - van Hoogenhuijze,N E, AU - Mol,F, AU - Laven,J S E, AU - Groenewoud,E R, AU - Traas,M A F, AU - Janssen,C A H, AU - Teklenburg,G, AU - de Bruin,J P, AU - van Oppenraaij,R H F, AU - Maas,J W M, AU - Moll,E, AU - Fleischer,K, AU - van Hooff,M H A, AU - de Koning,C H, AU - Cantineau,A E P, AU - Lambalk,C B, AU - Verberg,M, AU - van Heusden,A M, AU - Manger,A P, AU - van Rumste,M M E, AU - van der Voet,L F, AU - Pieterse,Q D, AU - Visser,J, AU - Brinkhuis,E A, AU - den Hartog,J E, AU - Glas,M W, AU - Klijn,N F, AU - van der Meer,S, AU - Bandell,M L, AU - Boxmeer,J C, AU - van Disseldorp,J, AU - Smeenk,J, AU - van Wely,M, AU - Eijkemans,M J C, AU - Torrance,H L, AU - Broekmans,F J M, PY - 2020/06/06/received PY - 2020/07/27/revised PY - 2020/12/9/pubmed PY - 2021/5/26/medline PY - 2020/12/8/entrez KW - ICSI KW - IVF KW - cumulative live birth KW - embryo implantation KW - endometrial biopsy catheter KW - endometrial injury KW - endometrial scratch KW - endometrium KW - live birth KW - pregnancy SP - 87 EP - 98 JF - Human reproduction (Oxford, England) JO - Hum Reprod VL - 36 IS - 1 N2 - STUDY QUESTION: Does endometrial scratching in women with one failed IVF/ICSI treatment affect the chance of a live birth of the subsequent fresh IVF/ICSI cycle? SUMMARY ANSWER: In this study, 4.6% more live births were observed in the scratch group, with a likely certainty range between -0.7% and +9.9%. WHAT IS KNOWN ALREADY: Since the first suggestion that endometrial scratching might improve embryo implantation during IVF/ICSI, many clinical trials have been conducted. However, due to limitations in sample size and study quality, it remains unclear whether endometrial scratching improves IVF/ICSI outcomes. STUDY DESIGN, SIZE, DURATION: The SCRaTCH trial was a non-blinded randomised controlled trial in women with one unsuccessful IVF/ICSI cycle and assessed whether a single endometrial scratch using an endometrial biopsy catheter would lead to a higher live birth rate after the subsequent IVF/ICSI treatment compared to no scratch. The study took place in 8 academic and 24 general hospitals. Participants were randomised between January 2016 and July 2018 by a web-based randomisation programme. Secondary outcomes included cumulative 12-month ongoing pregnancy leading to live birth rate. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with one previous failed IVF/ICSI treatment and planning a second fresh IVF/ICSI treatment were eligible. In total, 933 participants out of 1065 eligibles were included (participation rate 88%). MAIN RESULTS AND THE ROLE OF CHANCE: After the fresh transfer, 4.6% more live births were observed in the scratch compared to control group (110/465 versus 88/461, respectively, risk ratio (RR) 1.24 [95% CI 0.96-1.59]). These data are consistent with a true difference of between -0.7% and +9.9% (95% CI), indicating that while the largest proportion of the 95% CI is positive, scratching could have no or even a small negative effect. Biochemical pregnancy loss and miscarriage rate did not differ between the two groups: in the scratch group 27/153 biochemical pregnancy losses and 14/126 miscarriages occurred, while this was 19/130 and 17/111 for the control group (RR 1.21 (95% CI 0.71-2.07) and RR 0.73 (95% CI 0.38-1.40), respectively). After 12 months of follow-up, 5.1% more live births were observed in the scratch group (202/467 versus 178/466), of which the true difference most likely lies between -1.2% and +11.4% (95% CI). LIMITATIONS, REASONS FOR CAUTION: This study was not blinded. Knowledge of allocation may have been an incentive for participants allocated to the scratch group to continue treatment in situations where they may otherwise have cancelled or stopped. In addition, this study was powered to detect a difference in live birth rate of 9%. WIDER IMPLICATIONS OF THE FINDINGS: The results of this study are an incentive for further assessment of the efficacy and clinical implications of endometrial scratching. If a true effect exists, it may be smaller than previously anticipated or may be limited to specific groups of women undergoing IVF/ICSI. Studying this will require larger sample sizes, which will be provided by the ongoing international individual participant data-analysis (PROSPERO CRD42017079120). At present, endometrial scratching should not be performed outside of clinical trials. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by ZonMW, the Dutch organisation for funding healthcare research. J.S.E. Laven reports grants and personal fees from AnshLabs (Webster, Tx, USA), Ferring (Hoofddorp, The Netherlands) and Ministry of Health (CIBG, The Hague, The Netherlands) outside the submitted work. A.E.P. Cantineau reports 'other' from Ferring BV, personal fees from Up to date Hyperthecosis, 'other' from Theramex BV, outside the submitted work. E.R. Groenewoud reports grants from Titus Health Care during the conduct of the study. A.M. van Heusden reports personal fees from Merck Serono, personal fees from Ferring, personal fees from Goodlife, outside the submitted work. F.J.M. Broekmans reports personal fees as Member of the external advisory board for Ferring BV, The Netherlands, personal fees as Member of the external advisory board for Merck Serono, The Netherlands, personal fees as Member of the external advisory for Gedeon Richter, Belgium, personal fees from Educational activities for Ferring BV, The Netherlands, grants from Research support grant Merck Serono, grants from Research support grant Ferring, personal fees from Advisory and consultancy work Roche, outside the submitted work. C.B. Lambalk reports grants from Ferring, grants from Merck, grants from Guerbet, outside the submitted work. TRIAL REGISTRATION NUMBER: Registered in the Netherlands Trial Register (NL5193/NTR 5342). TRIAL REGISTRATION DATE: 31 July 2015. DATE OF FIRST PATIENT’S ENROLMENT: 26 January 2016. SN - 1460-2350 UR - https://www.unboundmedicine.com/medline/citation/33289528/Endometrial_scratching_in_women_with_one_failed_IVF/ICSI_cycle_outcomes_of_a_randomised_controlled_trial__SCRaTCH__ L2 - https://academic.oup.com/humrep/article-lookup/doi/10.1093/humrep/deaa268 DB - PRIME DP - Unbound Medicine ER -