Endometrial Scratch Trial

  • Research type

    Research Study

  • Full title

    A Multicentre Randomised Controlled Trial of Induced Endometrial Scratch in Women Undergoing First Time in Vitro Fertilisation (IVF)\n

  • IRAS ID

    196060

  • Contact name

    Mostafa Metwally

  • Contact email

    mostafa.metwally@sth.nhs.uk

  • Sponsor organisation

    Sheffield Teaching Hospitals NHS Foundation Trust

  • ISRCTN Number

    ISRCTN23800982

  • Duration of Study in the UK

    4 years, 10 months, days

  • Research summary

    Local endometrial trauma commonly known as endometrial scratch has been shown to improve pregnancy rates in women undergoing in vitro fertilisation (IVF) treatment, with or without Intracytoplasmic Sperm Injection (ICSI). The procedure has not yet been fully explored in women having IVF/ICSI treatment for the first time. The trial aims to examine the effect of an Endometrial Scratch (ES) performed in the midluteal phase prior to a first time IVF/ICSI cycle, on the chances of achieving a clinical pregnancy and live birth. \n\nThis will be a multi-centre, parallel group, randomised controlled trial including a 6 month internal pilot recruitment phase to justify whether or not the recruitment is feasible. The trial will recruit 1044 women over 30 months (including the feasibility phase) from approximately 10 Assisted Conception Units within the United Kingdom. \n\nIf a beneficial effect is seen in this group of women, this would have a significant bearing on the success rate of IVF/ICSI treatment with a potential significant cost saving to the NHS through decreasing the number of IVF/ICSI cycles necessary to achieve a pregnancy. Through improving success rates, such a procedure could also have the potential to improve the implementation of the practice of single embryo transfer, which would consequently have a large impact on the risks and costs associated with multiple pregnancies.\n

  • REC name

    South Central - Berkshire Research Ethics Committee

  • REC reference

    16/SC/0151

  • Date of REC Opinion

    24 Mar 2016

  • REC opinion

    Favourable Opinion