A randomised controlled trial to assess the clinical effectiveness and safety of the endometrial scratch procedure prior to first-time IVF, with or without ICSI

Mostafa Metwally; Robin Chatters; Munya Dimairo; Stephen Walters; Clare Pye; David White; Priya Bhide; Tim Chater; Ying Cheong; Meenakshi Choudhary; Tim Child; Andrew Drakeley; Isaac Evbuomwan; Tarek Gelbaya; Jan Grace; Philip Harris; Susan Laird; Sarah Martins da Silva; Lamiya Mohiyiddeen; Kirsty Pemberton; Nick Raine-Fenning; Madhurima Rajkhowa; Tracey Young; Judith Cohen

doi:10.1093/humrep/deab041

A randomised controlled trial to assess the clinical effectiveness and safety of the endometrial scratch procedure prior to first-time IVF, with or without ICSI

Mostafa Metwally (Lead / Corresponding author), Robin Chatters, Munya Dimairo, Stephen Walters, Clare Pye, David White, Priya Bhide, Tim Chater, Ying Cheong, Meenakshi Choudhary, Tim Child, Andrew Drakeley, Isaac Evbuomwan, Tarek Gelbaya, Jan Grace, Philip Harris, Susan Laird, Sarah Martins da Silva, Lamiya Mohiyiddeen, Kirsty PembertonNick Raine-Fenning, Madhurima Rajkhowa, Tracey Young, Judith Cohen

Research output: Contribution to journal › Article › peer-review

16 Citations (Scopus)

117 Downloads (Pure)

Abstract

Study Question: What is the clinical-effectiveness and safety of the endometrial scratch (ES) procedure compared to no ES, prior to usual first time in vitro fertilisation (IVF) treatment?

Summary Answer: ES was safe but did not improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF cycle, with or without intracytoplasmic sperm injection (ICSI).

What is Known Already: ES is an 'add-on' treatment that is available to women undergoing a first cycle of IVF, with or without ICSI, despite a lack of evidence to support its use.

Study Design, Size, Duration: This pragmatic, superiority, open-label, multi-centre, parallel-group randomised controlled trial involving 1048 women assessed the clinical effectiveness and safety of the ES procedure prior to first time IVF, with or without ICSI, between July 2016 and October 2019.

Participants/Materials, Setting, Methods: Participants aged 18-37 years undergoing their first cycle of IVF, with or without ICSI, were recruited from 16 UK fertility clinics and randomised (1:1) by a web-based system with restricted access rights that concealed allocation. Stratified block randomisation was used to allocate participants to TAU or ES in the mid-luteal phase followed by usual IVF with or without ICSI treatment. The primary outcome was live birth after completing 24 weeks gestation within 10.5 months of egg collection.

Main Results and the Role of Chance: In total, 1048 women randomised to TAU (n = 525) and ES (n = 523) were available for intention to treat analysis. In the ES group, 453 (86.6%) received the ES procedure. IVF, with or without ICSI, was received in 494 (94.1%) and 497 (95.0%) of ES and TAU participants respectively. Live birth rate was 37.1% (195/525) in the TAU and 38.6% (202/523) in the ES: an unadjusted absolute difference of 1.5% (95% CI -4.4% to 7.4%, P = 0.621). There were no statistical differences in secondary outcomes. Adverse events were comparable across groups.

Limitations, Reasons for Caution: A sham ES procedure was not undertaken in the control group, however, we do not believe this would have influenced the results as objective fertility outcomes were used.

Wider Implications of the Findings: This is the largest trial that is adequately powered to assess the impact of ES on women undergoing their first cycle of IVF. ES was safe, but did not significantly improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF or ICSI cycle. We recommend that ES is not undertaken in this population.

Original language	English
Pages (from-to)	1841-1853
Number of pages	13
Journal	Human Reproduction
Volume	36
Issue number	7
Early online date	29 May 2021
DOIs	https://doi.org/10.1093/humrep/deab041
Publication status	Published - Jul 2021

Keywords

endometrial scratch
assisted reproduction
IVF
live birth
randomised controlled trial
Live Birth
Randomised Controlled Trial
Assisted reproduction
Endometrial Scratch

ASJC Scopus subject areas

Obstetrics and Gynaecology
Reproductive Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1093/humrep/deab041Licence: CC BY

Final Published VersionFinal published version, 615 KBLicence: CC BY

Cite this

Metwally, M., Chatters, R., Dimairo, M., Walters, S., Pye, C., White, D., Bhide, P., Chater, T., Cheong, Y., Choudhary, M., Child, T., Drakeley, A., Evbuomwan, I., Gelbaya, T., Grace, J., Harris, P., Laird, S., da Silva, S. M., Mohiyiddeen, L., ... Cohen, J. (2021). A randomised controlled trial to assess the clinical effectiveness and safety of the endometrial scratch procedure prior to first-time IVF, with or without ICSI. Human Reproduction, 36(7), 1841-1853. https://doi.org/10.1093/humrep/deab041

@article{f67046936e724d2f957d54f0a7f2d65f,

title = "A randomised controlled trial to assess the clinical effectiveness and safety of the endometrial scratch procedure prior to first-time IVF, with or without ICSI",

abstract = "Study Question: What is the clinical-effectiveness and safety of the endometrial scratch (ES) procedure compared to no ES, prior to usual first time in vitro fertilisation (IVF) treatment?Summary Answer: ES was safe but did not improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF cycle, with or without intracytoplasmic sperm injection (ICSI).What is Known Already: ES is an 'add-on' treatment that is available to women undergoing a first cycle of IVF, with or without ICSI, despite a lack of evidence to support its use.Study Design, Size, Duration: This pragmatic, superiority, open-label, multi-centre, parallel-group randomised controlled trial involving 1048 women assessed the clinical effectiveness and safety of the ES procedure prior to first time IVF, with or without ICSI, between July 2016 and October 2019.Participants/Materials, Setting, Methods: Participants aged 18-37 years undergoing their first cycle of IVF, with or without ICSI, were recruited from 16 UK fertility clinics and randomised (1:1) by a web-based system with restricted access rights that concealed allocation. Stratified block randomisation was used to allocate participants to TAU or ES in the mid-luteal phase followed by usual IVF with or without ICSI treatment. The primary outcome was live birth after completing 24 weeks gestation within 10.5 months of egg collection.Main Results and the Role of Chance: In total, 1048 women randomised to TAU (n = 525) and ES (n = 523) were available for intention to treat analysis. In the ES group, 453 (86.6%) received the ES procedure. IVF, with or without ICSI, was received in 494 (94.1%) and 497 (95.0%) of ES and TAU participants respectively. Live birth rate was 37.1% (195/525) in the TAU and 38.6% (202/523) in the ES: an unadjusted absolute difference of 1.5% (95% CI -4.4% to 7.4%, P = 0.621). There were no statistical differences in secondary outcomes. Adverse events were comparable across groups.Limitations, Reasons for Caution: A sham ES procedure was not undertaken in the control group, however, we do not believe this would have influenced the results as objective fertility outcomes were used.Wider Implications of the Findings: This is the largest trial that is adequately powered to assess the impact of ES on women undergoing their first cycle of IVF. ES was safe, but did not significantly improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF or ICSI cycle. We recommend that ES is not undertaken in this population.",

keywords = "endometrial scratch, assisted reproduction, IVF, live birth, randomised controlled trial, Live Birth, Randomised Controlled Trial, Assisted reproduction, Endometrial Scratch",

author = "Mostafa Metwally and Robin Chatters and Munya Dimairo and Stephen Walters and Clare Pye and David White and Priya Bhide and Tim Chater and Ying Cheong and Meenakshi Choudhary and Tim Child and Andrew Drakeley and Isaac Evbuomwan and Tarek Gelbaya and Jan Grace and Philip Harris and Susan Laird and {da Silva}, {Sarah Martins} and Lamiya Mohiyiddeen and Kirsty Pemberton and Nick Raine-Fenning and Madhurima Rajkhowa and Tracey Young and Judith Cohen",

note = "Funded by the National Institute of Health Research. Stephen Walters is an National Institute for Health Research (NIHR) Senior Investigator (2018 to present) and was a member of the following during the project: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Clinical Trials and Evaluation Committee (2011-2017), NIHR HTA Commissioning Strategy Group (2012 to 2017); NIHR Programme Grants for Applied Research Committee (2020 to present); NIHR Pre doctoral Fellowship Committee (2019 to present). Dr. Martins da Silva reports grants from AstraZeneca, during the conduct of the study; and is Associate editor of Human Reproduction and Editorial Board member of Reproduction and Fertility. Dr. Bhide reports grants from Bart's Charity and grants and non-financial support from Pharmasure Pharmaceuticals outside the submitted work.",

year = "2021",

month = jul,

doi = "10.1093/humrep/deab041",

language = "English",

volume = "36",

pages = "1841--1853",

journal = "Human Reproduction",

issn = "0268-1161",

publisher = "Oxford University Press",

number = "7",

}

Metwally, M, Chatters, R, Dimairo, M, Walters, S, Pye, C, White, D, Bhide, P, Chater, T, Cheong, Y, Choudhary, M, Child, T, Drakeley, A, Evbuomwan, I, Gelbaya, T, Grace, J, Harris, P, Laird, S, da Silva, SM, Mohiyiddeen, L, Pemberton, K, Raine-Fenning, N, Rajkhowa, M, Young, T & Cohen, J 2021, 'A randomised controlled trial to assess the clinical effectiveness and safety of the endometrial scratch procedure prior to first-time IVF, with or without ICSI', Human Reproduction, vol. 36, no. 7, pp. 1841-1853. https://doi.org/10.1093/humrep/deab041

A randomised controlled trial to assess the clinical effectiveness and safety of the endometrial scratch procedure prior to first-time IVF, with or without ICSI. / Metwally, Mostafa (Lead / Corresponding author); Chatters, Robin; Dimairo, Munya et al.
In: Human Reproduction, Vol. 36, No. 7, 07.2021, p. 1841-1853.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - A randomised controlled trial to assess the clinical effectiveness and safety of the endometrial scratch procedure prior to first-time IVF, with or without ICSI

AU - Metwally, Mostafa

AU - Chatters, Robin

AU - Dimairo, Munya

AU - Walters, Stephen

AU - Pye, Clare

AU - White, David

AU - Bhide, Priya

AU - Chater, Tim

AU - Cheong, Ying

AU - Choudhary, Meenakshi

AU - Child, Tim

AU - Drakeley, Andrew

AU - Evbuomwan, Isaac

AU - Gelbaya, Tarek

AU - Grace, Jan

AU - Harris, Philip

AU - Laird, Susan

AU - da Silva, Sarah Martins

AU - Mohiyiddeen, Lamiya

AU - Pemberton, Kirsty

AU - Raine-Fenning, Nick

AU - Rajkhowa, Madhurima

AU - Young, Tracey

AU - Cohen, Judith

N1 - Funded by the National Institute of Health Research. Stephen Walters is an National Institute for Health Research (NIHR) Senior Investigator (2018 to present) and was a member of the following during the project: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Clinical Trials and Evaluation Committee (2011-2017), NIHR HTA Commissioning Strategy Group (2012 to 2017); NIHR Programme Grants for Applied Research Committee (2020 to present); NIHR Pre doctoral Fellowship Committee (2019 to present). Dr. Martins da Silva reports grants from AstraZeneca, during the conduct of the study; and is Associate editor of Human Reproduction and Editorial Board member of Reproduction and Fertility. Dr. Bhide reports grants from Bart's Charity and grants and non-financial support from Pharmasure Pharmaceuticals outside the submitted work.

PY - 2021/7

Y1 - 2021/7

N2 - Study Question: What is the clinical-effectiveness and safety of the endometrial scratch (ES) procedure compared to no ES, prior to usual first time in vitro fertilisation (IVF) treatment?Summary Answer: ES was safe but did not improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF cycle, with or without intracytoplasmic sperm injection (ICSI).What is Known Already: ES is an 'add-on' treatment that is available to women undergoing a first cycle of IVF, with or without ICSI, despite a lack of evidence to support its use.Study Design, Size, Duration: This pragmatic, superiority, open-label, multi-centre, parallel-group randomised controlled trial involving 1048 women assessed the clinical effectiveness and safety of the ES procedure prior to first time IVF, with or without ICSI, between July 2016 and October 2019.Participants/Materials, Setting, Methods: Participants aged 18-37 years undergoing their first cycle of IVF, with or without ICSI, were recruited from 16 UK fertility clinics and randomised (1:1) by a web-based system with restricted access rights that concealed allocation. Stratified block randomisation was used to allocate participants to TAU or ES in the mid-luteal phase followed by usual IVF with or without ICSI treatment. The primary outcome was live birth after completing 24 weeks gestation within 10.5 months of egg collection.Main Results and the Role of Chance: In total, 1048 women randomised to TAU (n = 525) and ES (n = 523) were available for intention to treat analysis. In the ES group, 453 (86.6%) received the ES procedure. IVF, with or without ICSI, was received in 494 (94.1%) and 497 (95.0%) of ES and TAU participants respectively. Live birth rate was 37.1% (195/525) in the TAU and 38.6% (202/523) in the ES: an unadjusted absolute difference of 1.5% (95% CI -4.4% to 7.4%, P = 0.621). There were no statistical differences in secondary outcomes. Adverse events were comparable across groups.Limitations, Reasons for Caution: A sham ES procedure was not undertaken in the control group, however, we do not believe this would have influenced the results as objective fertility outcomes were used.Wider Implications of the Findings: This is the largest trial that is adequately powered to assess the impact of ES on women undergoing their first cycle of IVF. ES was safe, but did not significantly improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF or ICSI cycle. We recommend that ES is not undertaken in this population.

AB - Study Question: What is the clinical-effectiveness and safety of the endometrial scratch (ES) procedure compared to no ES, prior to usual first time in vitro fertilisation (IVF) treatment?Summary Answer: ES was safe but did not improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF cycle, with or without intracytoplasmic sperm injection (ICSI).What is Known Already: ES is an 'add-on' treatment that is available to women undergoing a first cycle of IVF, with or without ICSI, despite a lack of evidence to support its use.Study Design, Size, Duration: This pragmatic, superiority, open-label, multi-centre, parallel-group randomised controlled trial involving 1048 women assessed the clinical effectiveness and safety of the ES procedure prior to first time IVF, with or without ICSI, between July 2016 and October 2019.Participants/Materials, Setting, Methods: Participants aged 18-37 years undergoing their first cycle of IVF, with or without ICSI, were recruited from 16 UK fertility clinics and randomised (1:1) by a web-based system with restricted access rights that concealed allocation. Stratified block randomisation was used to allocate participants to TAU or ES in the mid-luteal phase followed by usual IVF with or without ICSI treatment. The primary outcome was live birth after completing 24 weeks gestation within 10.5 months of egg collection.Main Results and the Role of Chance: In total, 1048 women randomised to TAU (n = 525) and ES (n = 523) were available for intention to treat analysis. In the ES group, 453 (86.6%) received the ES procedure. IVF, with or without ICSI, was received in 494 (94.1%) and 497 (95.0%) of ES and TAU participants respectively. Live birth rate was 37.1% (195/525) in the TAU and 38.6% (202/523) in the ES: an unadjusted absolute difference of 1.5% (95% CI -4.4% to 7.4%, P = 0.621). There were no statistical differences in secondary outcomes. Adverse events were comparable across groups.Limitations, Reasons for Caution: A sham ES procedure was not undertaken in the control group, however, we do not believe this would have influenced the results as objective fertility outcomes were used.Wider Implications of the Findings: This is the largest trial that is adequately powered to assess the impact of ES on women undergoing their first cycle of IVF. ES was safe, but did not significantly improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF or ICSI cycle. We recommend that ES is not undertaken in this population.

KW - endometrial scratch

KW - assisted reproduction

KW - IVF

KW - live birth

KW - randomised controlled trial

KW - Live Birth

KW - Randomised Controlled Trial

KW - Assisted reproduction

KW - Endometrial Scratch

U2 - 10.1093/humrep/deab041

DO - 10.1093/humrep/deab041

M3 - Article

C2 - 34050362

SN - 0268-1161

VL - 36

SP - 1841

EP - 1853

JO - Human Reproduction

JF - Human Reproduction

IS - 7

ER -

A randomised controlled trial to assess the clinical effectiveness and safety of the endometrial scratch procedure prior to first-time IVF, with or without ICSI

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Fingerprint

Cite this